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OpenTrials
Completed

NCT Number: NCT03279302

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

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

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance CRU

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glepaglutide

Drug

Solution for injection

Other names: ZP1848

Primary outcomes

  1. Pharmacokinetic parameter - half life

    Time frame: Day 0 up to Day 73

    Half life of glepaglutide and active metabolites

  2. Pharmacokinetic parameter - total body clearance

    Time frame: Day 0 to Day 22

    Total body clearance after IV administration

  3. Pharmacokinetic parameter - Apparent clearance

    Time frame: Day 0 to Day 73

    CL/F for subcutaneous doses

  4. Pharmacokinetic parameter - Volume of distribution

    Time frame: Day 0- Day 22

    Volume of distribution after IV dosing

  5. Pharmacokinetic parameter - apparent volume of distribution

    Time frame: Day 0 to Day 73

    Vss/F and Vz/F for subcutaneous doses

Secondary outcomes

  1. Pharmacokinetic parameter - Cmax

    Time frame: Day 0 to Day 73

    Maximum observed plasma concentration

  2. Pharmacokinetic parameter - tmax

    Time frame: Day 0 to Day 73

    time of maximum observed plasma concentration

  3. Pharmacokinetic parameter - AUC

    Time frame: Day 0 to Day 73

    Area under the curve

  4. Pharmacodynamic parameter - plasma citrulline levels

    Time frame: Day 0 to Day 73

    change in plasma citrulline levels

  5. ADA incidence

    Time frame: Day 0 to Day 73

    Overall incidence of anti-glepaglutide antibodies

  6. Safety and tolerability - AEs

    Time frame: Day 0 to Day 73

    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

    12 lead electrocardiogram parameters

Sponsors and collaborators

Lead sponsor

Zealand Pharma

Industry

Registry information

Official study title

A Phase 1, Open-Label, Partially Randomized, 3-Part, Parallel Group Trial to Evaluate the Pharmacokinetic Profile of Glepaglutide (ZP1848) After a Single Intravenous Injection and After Multiple Subcutaneous Injections in Healthy Subjects

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 12, 2017
Registry last updated
Dec 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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