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Trial · Interventional

CompletedPhase 1Registry data

Pharmacokinetic Profile of Glepaglutide After a Single Injection in Subjects With Varying Degrees of Renal Function

NCTNCT04178447 (opens ClinicalTrials.gov in a new tab)Other idZP1848-18131Other id2019-001466-15Other id2019

Overview

Status
Completed
Phase
Phase 1
Enrollment
16 participants (actual)
Sponsor
Zealand Pharma · Industry
Design
Not randomized · Open label (no masking)
Countries
2 countries

Hungary, Poland

Start
10 Dec 2019
Primary completion
14 Jul 2020
Completion
14 Jul 2020
First posted
26 Nov 2019
Last update posted
18 Nov 2020
Conditions
Renal Impairment

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 1

    Pharmacokinetic Profile of Glepaglutide After a Single Injection in Subjects With Varying Degrees of Renal Function

    NCT04178447

    10 Dec 2019 to 14 Jul 2020

Registry summary

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

This is two stage design, open-label, multi-center, non-randomized trial evaluating the PK of a single, subcutaneous dose of 10 mg glepaglutide in subjects with varying degrees of renal function. The renal function will be calculated by the estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) equation.

Interventions

  • GlepaglutideDrug

Arms4

  • Experimental

    Group 1: ESRD subjects not on dialysis or severe RI

    subjects with eGFR \<15 mL/min/1.73 m2) or (eGFR 15 to \<30 mL/min/1.73 m2)

  • Experimental

    Group 2: normal renal function

    subjects with eGFR ≥90 mL/min/1.73 m2

  • Experimental

    Group 3: moderate RI

    subjects with eGFR 30 to \<60 mL/min/1.73 m2

  • Experimental

    Group 4: mild RI

    subjects with eGFR 60 to \<90 mL/min/1.73 m2

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Pharmacokinetic Variables

    Time frame · 11 days

    Registry description

    AUC0-168 area under the concentration-time curve (AUC) from time 0 to 168 hours Cmax maximum observed plasma concentration

Secondary outcomes(1)
  1. Safety Variables

    Time frame · 11 days

    Registry description

    Number of subject with AE/SAE as a measure of safety and tolerability

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.

More studies

1 study on this page

PubMed tag: none · 2023

Corrected

Pharmacokinetics, Safety, and Tolerability of Glepaglutide, a Long-Acting GLP-2 Analog, in Subjects with Renal Impairment.

Agersnap et al. 2023Clinical pharmacokineticscited by 6

PMID 36811175PMC10085944DOI 10.1007/s40262-023-01215-9PUB-36811175

Free to read · publisher termsCC BY-NC

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * All subjects 1. Able to understand and willing to sign the informed consent 2. eGFR values as defined in in the arms 3. Willing and able to comply with the study requirements 4. Male and female subjects age 18 to 70 years (both inclusive) at the time of informed consent 5. BMI 20.0 - 30.0 kg/m2 both inclusive 6. Must be willing to comply with the contraception, sperm-donation requirements, and study restrictions. Renally Impaired Subjects (in Addition) 7. Subject has a stable disease, including disease(s) associated with renal impairment, under medical control (ie, no changes in medication within 30 days prior to study drug administration). Stable renal impairment, defined as no clinically significant change in disease status within 3 months before screening. Exclusion Criteria: All Subjects 1. Suspicion of hypersensitivity, intolerance, or allergy to glepaglutide 2. History of alcohol or drug abuse 3. Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, clinically significant abnormalities on 12-lead ECG, or laboratory tests at Screening that the Investigator judges as likely to interfere with the objectives of the study or the safety of the subject except for conditions associated with renal impairment in subjects with renal impairment 4. Uncontrolled treated/untreated hypertension (defined as a mean of 3 repeated measurements for systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg); current or documented history of repeated clinically significant hypotension or severe episodes of orthostatic hypotension (systolic blood pressure \< 90 mmHg and/or diastolic blood pressure \< 50 mmHg) 5. Acute illness within 14 days prior to dosing unless mild in severity and approved by the Investigator and Sponsor's medical representative 6. Presence of active infection requiring antibiotics. Ingestion of alcohol within 72 hours prior to study drug administration and during PK sampling period including Follow-Up 7. Participation in another investigational drug study within 30 days prior to study drug administration or exposure to more than three new investigational agents within 12 months prior to study drug administration 8. Previous exposure to GLP-1, GLP-2, human growth hormone, somatostatin, or analogues thereof within 3 months prior to Screening. Use of dipeptidyl peptidase-4 inhibitors within 3 months prior to Screening 9. Previous exposure to glepaglutide 10. Donation or loss of more than 450 mL blood during the 3 months before the start of Screening 11. Female subjects who are breastfeeding, pregnant, or planning to become pregnant during the study 12. Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) or human immunodeficiency virus antibodies (anti-HIV)-1/2, unless the absence of an active hepatitis B/C infection is confirmed by a polymerase chain reaction (PCR) test, at Screening 13. Positive urine screen of drugs of abuse (if not due to concomitant medication) or alcohol breath test at Screening and/or Day -1 14. Legal incapacity or limited legal capacity Renally Impaired Subjects (in Addition) 15. Acute renal failure (as judged by the Investigator) 16. Renal impairment requiring dialysis 17. History of kidney transplant regardless of functionality 18. Serum albumin concentration \<25 g/L 19. Haemoglobin concentration \<100 g/L 20. Medications known to affect the elimination of serum creatinine (e.g., trimethoprim or cimetidine) and competitors of renal tubular secretion (e.g., probenecid) within 60 days prior to study drug administration Subjects With Normal Renal Function (in Addition) 21. Significant medical history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator -

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