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Trial · Interventional

CompletedPhase 1Registry data

Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects

Overview

Status
Completed
Phase
Phase 1
Enrollment
75 participants (actual)
Sponsor
Zealand Pharma · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
4 Sept 2017
Primary completion
18 Dec 2017
Completion
18 Dec 2017
First posted
12 Sept 2017
Last update posted
22 Dec 2017
Conditions
Healthy Subjects

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20172018
  1. Ph 1

    Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects

    NCT03279302

    4 Sept 2017 to 18 Dec 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The primary objective of the trial is to characterize the pharmacokinetic (PK) profiles of glepaglutide and its primary active metabolites following once-daily and once-weekly subcutaneous (SC) injections and after a single intravenous (IV) infusion in healthy subjects. Glepaglutide is a proposed International Nonproprietary Name for ZP1848

Interventions

  • GlepaglutideDrug

Arms5

  • Experimental

    Group A

    1 mg glepaglutide once daily, given as single SC injections on Days 1 to 7

  • Experimental

    Group B

    5 mg glepaglutide once daily, given as single SC injections on Days 1 to 7

  • Experimental

    Group C

    5 mg glepaglutide once weekly, given as single SC injections on Days 1, 8, 15, 22, 29, and 36

  • Experimental

    Group D

    10 mg glepaglutide once weekly, given as single SC injections on Days 1, 8, 15, 22, 29, and 36

  • Experimental

    Group E

    1 mg glepaglutide, given as an IV infusion at a rate of 4 mg/h for 15 minutes on Day 1

Primary outcomes5

Outcomes the sponsor listed as primary.

  1. Pharmacokinetic parameter - half life

    Time frame · Day 0 up to Day 73

    Registry description

    Half life of glepaglutide and active metabolites

  2. Pharmacokinetic parameter - total body clearance

    Time frame · Day 0 to Day 22

    Registry description

    Total body clearance after IV administration

  3. Pharmacokinetic parameter - Apparent clearance

    Time frame · Day 0 to Day 73

    Registry description

    CL/F for subcutaneous doses

  4. Pharmacokinetic parameter - Volume of distribution

    Time frame · Day 0- Day 22

    Registry description

    Volume of distribution after IV dosing

  5. Pharmacokinetic parameter - apparent volume of distribution

    Time frame · Day 0 to Day 73

    Registry description

    Vss/F and Vz/F for subcutaneous doses

Secondary outcomes(7)
  1. Pharmacokinetic parameter - Cmax

    Time frame · Day 0 to Day 73

    Registry description

    Maximum observed plasma concentration

  2. Pharmacokinetic parameter - tmax

    Time frame · Day 0 to Day 73

    Registry description

    time of maximum observed plasma concentration

  3. Pharmacokinetic parameter - AUC

    Time frame · Day 0 to Day 73

    Registry description

    Area under the curve

  4. Pharmacodynamic parameter - plasma citrulline levels

    Time frame · Day 0 to Day 73

    Registry description

    change in plasma citrulline levels

  5. ADA incidence

    Time frame · Day 0 to Day 73

    Registry description

    Overall incidence of anti-glepaglutide antibodies

  6. Safety and tolerability - AEs

    Time frame · Day 0 to Day 73

    Registry description

    Incidence, nature, and severity of adverse events, abnormal clinical laboratory tests, and injection site reactions

  7. Safety and tolerability - ECGs

    Time frame · Day 0 to Day 73

    Registry description

    12 lead electrocardiogram parameters

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

7 results

Pharmacokinetics of Glepaglutide, A Long-Acting Glucagon-Like Peptide-2 Analogue: A Study in Healthy Subjects.

Agersnap et al. 2022Clinical drug investigationcited by 12

PMID 36323988PMC9705454DOI 10.1007/s40261-022-01210-1PUB-36323988

Free to read · publisher termsCC BY-NC7 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations * Body Mass index between 18 and 30.0 kg/m2 * Able to comply with all the trial procedures * females will not be pregnant or lactating * If female of childbearing potential or male agree to use contraception as defined in the protocol * Male subjects must also be willing to refrain from donating sperm from trial Check-in until 90 days after the last dose Exclusion Criteria: * Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance * History of bowel obstruction, stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and/or cholecystectomy or hernia repair will be allowed). * Clinically significant abnormality on 12-lead ECG * Clinically significant abnormality in hematology, clinical chemistry, or urinalysis * History of alcoholism or drug/chemical abuse within 2 years * Alcohol consumption of \> 21 units per week for males and \> 14 units for females * Positive urine drug screen * Positive hepatitis panel and/or positive human immunodeficiency test * Receipt of any investigational product within 30 days or 5 half-lives * Previous exposure to GLP-1, GLP-2, human growth hormone, or analogs thereof 30 days prior to Check-in * Use or intend to use any medications/products known to be strong inhibitors or strong inducers of cytochrome P450 3A enzyme, including St. John's wort * Use of tobacco, smoking cessation products, or products containing nicotine (including but not limited to cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine lozenges, or nicotine gum ) within 3 months prior to Screening * Receipt of blood products within 2 months prior to Check-in and throughout the trial. * Donation of blood or significant blood loss from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening and throughout the trial. * Poor peripheral venous access.

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