Absorption, metabolism and excretion of once-weekly somapacitan, a long-acting growth hormone derivative, after single subcutaneous dosing in human subjects.

Helleberg H, Bjelke M, Damholt BB, Pedersen PJ, Rasmussen MH

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences1 Oct 2021Cited by 12 (Europe PMC)

PMID34601071DOI10.1016/j.ejps.2021.106030PepBankPUB-34601071

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study14

14 results from studies that gave the peptide. 14 results from people.

01HumanNon-randomized trialPharmacokinetics
In healthy men, 94.0% of a somapacitan dose was recovered as related material 28 days after dosing.
In plain wordsIn healthy men, 94.0% of a somapacitan dose was recovered as related material after 28 days.
Peptide
Somapacitan
Outcome
Not applicableTotal dose recovery at 28 days
Study
n = 7
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
6 mg somapacitan containing tritium-labelled somapacitan 20 MBq · subcutaneous · Single doseAs given in this study (human).
Measurements
Total dose recovery as 3H-somapacitan-related material
94 % of administered dose
28 days after dosing
Source sentences
Summary
Twenty-eight days after dosing, 94.0% of the administered dose was recovered as [³H]-somapacitan-related material, most of which was excreted in urine (80.9%); 12.9% was excreted in faeces, and an insignificant amount (0.2%) was exhaled in expired air.
1 context sentence(design, population, supporting numbers)
Summary · context
Seven healthy males received a single subcutaneous dose of 6 mg somapacitan containing [³H]-somapacitan 20 MBq.
Report a problemFND-3460107101
02HumanNon-randomized trialPharmacokinetics
In healthy men, 80.9% of a somapacitan dose was excreted in urine by 28 days.
In plain wordsIn healthy men, 80.9% of a somapacitan dose was excreted in urine by 28 days.
Peptide
Somapacitan
Outcome
Not applicableUrinary dose recovery
Study
n = 7
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
6 mg somapacitan containing tritium-labelled somapacitan 20 MBq · subcutaneous · Single doseAs given in this study (human).
Measurements
Urinary excretion
80.9 % of administered dose
28 days after dosing
Source sentences
Summary
Twenty-eight days after dosing, 94.0% of the administered dose was recovered as [³H]-somapacitan-related material, most of which was excreted in urine (80.9%); 12.9% was excreted in faeces, and an insignificant amount (0.2%) was exhaled in expired air.
1 context sentence(design, population, supporting numbers)
Summary · context
Seven healthy males received a single subcutaneous dose of 6 mg somapacitan containing [³H]-somapacitan 20 MBq.
Report a problemFND-3460107102
03HumanNon-randomized trialPharmacokinetics
In healthy men, 12.9% of a somapacitan dose was excreted in faeces by 28 days.
In plain wordsIn healthy men, 12.9% of a somapacitan dose was excreted in faeces by 28 days.
Peptide
Somapacitan
Outcome
Not applicableFaecal dose recovery
Study
n = 7
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
6 mg somapacitan containing tritium-labelled somapacitan 20 MBq · subcutaneous · Single doseAs given in this study (human).
Measurements
Faecal excretion
12.9 % of administered dose
28 days after dosing
Source sentences
Summary
Twenty-eight days after dosing, 94.0% of the administered dose was recovered as [³H]-somapacitan-related material, most of which was excreted in urine (80.9%); 12.9% was excreted in faeces, and an insignificant amount (0.2%) was exhaled in expired air.
1 context sentence(design, population, supporting numbers)
Summary · context
Seven healthy males received a single subcutaneous dose of 6 mg somapacitan containing [³H]-somapacitan 20 MBq.
Report a problemFND-3460107103
04HumanNon-randomized trialPharmacokinetics
In healthy men, 0.2% of a somapacitan dose was exhaled in expired air by 28 days.
In plain wordsIn healthy men, 0.2% of a somapacitan dose was exhaled by 28 days.
Peptide
Somapacitan
Outcome
Not applicableExpired air dose recovery
Study
n = 7
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
6 mg somapacitan containing tritium-labelled somapacitan 20 MBq · subcutaneous · Single doseAs given in this study (human).
Measurements
Exhaled in expired air
0.2 % of administered dose
28 days after dosing
Source sentences
Summary
Twenty-eight days after dosing, 94.0% of the administered dose was recovered as [³H]-somapacitan-related material, most of which was excreted in urine (80.9%); 12.9% was excreted in faeces, and an insignificant amount (0.2%) was exhaled in expired air.
1 context sentence(design, population, supporting numbers)
Summary · context
Seven healthy males received a single subcutaneous dose of 6 mg somapacitan containing [³H]-somapacitan 20 MBq.
Report a problemFND-3460107104
05HumanNon-randomized trialPharmacokinetics
In healthy men, somapacitan-related material had apparently consistent PK properties across plasma, serum and blood.
In plain wordsIn healthy men, somapacitan-related material had apparently similar behavior in plasma, serum and blood.
Peptide
Somapacitan
Outcome
Direction not reportedPK across blood matrices
Study
n = 7
Comparator
Plasma, serum and blood
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
6 mg somapacitan containing tritium-labelled somapacitan 20 MBq · subcutaneous · Single doseAs given in this study (human).
Source sentences
Summary
PK properties of [³H]-somapacitan-related material appeared to be consistent across plasma, serum and blood.
1 context sentence(design, population, supporting numbers)
Summary · context
Seven healthy males received a single subcutaneous dose of 6 mg somapacitan containing [³H]-somapacitan 20 MBq.
Report a problemFND-3460107105
06HumanNon-randomized trialPharmacokinetics
In healthy men given somapacitan, abundant plasma metabolites P1, M1 and M1B and urine metabolites M4 and M5 were identified.
In plain wordsIn healthy men, tests identified three main somapacitan breakdown products in plasma and two in urine.
Peptide
Somapacitan
Outcome
Not applicableAbundant metabolite identities
Study
n = 7
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
6 mg somapacitan containing tritium-labelled somapacitan 20 MBq · subcutaneous · Single doseAs given in this study (human).
Source sentences
Summary
Three abundant plasma metabolites (P1, M1 and M1B) and two abundant urine metabolites (M4 and M5) were identified.
1 context sentence(design, population, supporting numbers)
Summary · context
Seven healthy males received a single subcutaneous dose of 6 mg somapacitan containing [³H]-somapacitan 20 MBq.
Report a problemFND-3460107106
07HumanNon-randomized trialPharmacokinetics
In healthy men, intact somapacitan accounted for 59% of total exposure to somapacitan-related material.
In plain wordsIn healthy men, intact somapacitan accounted for 59% of total exposure to drug-related material.
Peptide
Somapacitan
Outcome
Not applicableIntact somapacitan exposure fraction
Study
n = 7
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
6 mg somapacitan containing tritium-labelled somapacitan 20 MBq · subcutaneous · Single doseAs given in this study (human).
Measurements
Intact somapacitan share of total exposure
59 % of total exposure
All somapacitan-related material
Source sentences
Summary
The total exposure of intact somapacitan accounted for 59% of the total exposure of all somapacitan-related material, P1 accounted for 21% and M1 plus M1B accounted for 12%.
1 context sentence(design, population, supporting numbers)
Summary · context
Seven healthy males received a single subcutaneous dose of 6 mg somapacitan containing [³H]-somapacitan 20 MBq.
Report a problemFND-3460107107
08HumanNon-randomized trialPharmacokinetics
In healthy men given somapacitan, P1 accounted for 21% of total exposure to somapacitan-related material.
In plain wordsIn healthy men, P1 accounted for 21% of total exposure to somapacitan-related material.
Peptide
Somapacitan
Outcome
Not applicableP1 exposure fraction
Study
n = 7
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
6 mg somapacitan containing tritium-labelled somapacitan 20 MBq · subcutaneous · Single doseAs given in this study (human).
Measurements
P1 share of total exposure
21 % of total exposure
All somapacitan-related material
Source sentences
Summary
The total exposure of intact somapacitan accounted for 59% of the total exposure of all somapacitan-related material, P1 accounted for 21% and M1 plus M1B accounted for 12%.
1 context sentence(design, population, supporting numbers)
Summary · context
Seven healthy males received a single subcutaneous dose of 6 mg somapacitan containing [³H]-somapacitan 20 MBq.
Report a problemFND-3460107108
09HumanNon-randomized trialPharmacokinetics
In healthy men given somapacitan, M1 and M1B together accounted for 12% of total exposure to somapacitan-related material.
In plain wordsIn healthy men, M1 and M1B together accounted for 12% of total exposure to somapacitan-related material.
Peptide
Somapacitan
Outcome
Not applicableM1 plus M1B exposure fraction
Study
n = 7
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
6 mg somapacitan containing tritium-labelled somapacitan 20 MBq · subcutaneous · Single doseAs given in this study (human).
Measurements
M1 plus M1B share of total exposure
12 % of total exposure
All somapacitan-related material
Source sentences
Summary
The total exposure of intact somapacitan accounted for 59% of the total exposure of all somapacitan-related material, P1 accounted for 21% and M1 plus M1B accounted for 12%.
1 context sentence(design, population, supporting numbers)
Summary · context
Seven healthy males received a single subcutaneous dose of 6 mg somapacitan containing [³H]-somapacitan 20 MBq.
Report a problemFND-3460107109
10HumanNon-randomized trialPharmacokinetics
In healthy men given somapacitan, urinary M4 accounted for 37% of dosed radioactivity.
In plain wordsIn healthy men given somapacitan, urinary M4 accounted for 37% of the dose's radioactivity.
Peptide
Somapacitan
Outcome
Not applicableM4 urinary radioactivity fraction
Study
n = 7
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
6 mg somapacitan containing tritium-labelled somapacitan 20 MBq · subcutaneous · Single doseAs given in this study (human).
Measurements
M4 share of dosed radioactivity
37 % of dosed radioactivity
Urine
Source sentences
Summary
M4 and M5 were the most abundant urine metabolites and accounted for 37% and 8% of the dosed [³H]-somapacitan radioactivity, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Seven healthy males received a single subcutaneous dose of 6 mg somapacitan containing [³H]-somapacitan 20 MBq.
Report a problemFND-3460107110
11HumanNon-randomized trialPharmacokinetics
In healthy men given somapacitan, urinary M5 accounted for 8% of dosed radioactivity.
In plain wordsIn healthy men given somapacitan, urinary M5 accounted for 8% of the dose's radioactivity.
Peptide
Somapacitan
Outcome
Not applicableM5 urinary radioactivity fraction
Study
n = 7
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
6 mg somapacitan containing tritium-labelled somapacitan 20 MBq · subcutaneous · Single doseAs given in this study (human).
Measurements
M5 share of dosed radioactivity
8 % of dosed radioactivity
Urine
Source sentences
Summary
M4 and M5 were the most abundant urine metabolites and accounted for 37% and 8% of the dosed [³H]-somapacitan radioactivity, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Seven healthy males received a single subcutaneous dose of 6 mg somapacitan containing [³H]-somapacitan 20 MBq.
Report a problemFND-3460107111
12HumanNon-randomized trialPharmacokinetics
In healthy men, no intact somapacitan was found in excreta after dosing.
In plain wordsIn healthy men, no intact somapacitan was found in excreta after dosing.
Peptide
Somapacitan
Outcome
Not applicableIntact somapacitan in excreta
Study
n = 7
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
6 mg somapacitan containing tritium-labelled somapacitan 20 MBq · subcutaneous · Single doseAs given in this study (human).
Source sentences
Summary
No intact somapacitan was found in excreta.
1 context sentence(design, population, supporting numbers)
Summary · context
Seven healthy males received a single subcutaneous dose of 6 mg somapacitan containing [³H]-somapacitan 20 MBq.
Report a problemFND-3460107112
13HumanNon-randomized trialSafety outcome
In healthy men given somapacitan, two subjects had six mild adverse events judged unlikely related to the trial product.
In plain wordsIn healthy men given somapacitan, two subjects had six mild adverse events judged unlikely related to treatment.
Peptide
Somapacitan
Outcome
Not applicableAdverse events
Study
n = 7
Outcome group
Adverse events · Whole body
Studied dose
6 mg somapacitan containing tritium-labelled somapacitan 20 MBq · subcutaneous · Single doseAs given in this study (human).
Measurements
Subjects with adverse events
2 subjects
Seven healthy males
Adverse events
6 events
Seven healthy males
Source sentences
Summary
Two subjects had six adverse events (AEs); all were mild in severity and unlikely to be related to trial product.
1 context sentence(design, population, supporting numbers)
Summary · context
Seven healthy males received a single subcutaneous dose of 6 mg somapacitan containing [³H]-somapacitan 20 MBq.
Report a problemFND-3460107113
14HumanNon-randomized trialPharmacokinetics
In healthy men, small urinary metabolite fragments indicated extensive somapacitan degradation and biodegradability.
In plain wordsIn healthy men, small urine fragments showed that somapacitan extensively broke into smaller products.
Peptide
Somapacitan
Outcome
Not applicableExtensive metabolic degradation
Study
n = 7
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
6 mg somapacitan containing tritium-labelled somapacitan 20 MBq · subcutaneous · Single doseAs given in this study (human).
Source sentences
Summary
The low molecular weights of identified urine metabolites demonstrate that somapacitan was extensively degraded to small residual fragments that were excreted (fully biodegradable).
1 context sentence(design, population, supporting numbers)
Summary · context
Seven healthy males received a single subcutaneous dose of 6 mg somapacitan containing [³H]-somapacitan 20 MBq.
Report a problemFND-3460107114

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT02962440

A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects

Novo Nordisk A/Sn = 7Nov 2016 to Jan 2017

Healthy

Trial page ClinicalTrials.govUpdated 7 Jun 2017

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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