Current partner codePEPTIDESDE
NCT03279302·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

75

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Glepaglutide

Solution for injection

Timeline

From registration to results.

  1. First posted

    Sep 12, 2017

  2. Study start

    Sep 4, 2017

  3. Primary completion

    Dec 18, 2017

  4. Study completion

    Dec 18, 2017

  5. Results posted

    Not reported

  6. Registry updated

    Dec 22, 2017

Outcomes

What the study measures.

Primary outcomes

Pharmacokinetic parameter - half life

Time frame · Day 0 up to Day 73

Half life of glepaglutide and active metabolites

Pharmacokinetic parameter - total body clearance

Time frame · Day 0 to Day 22

Total body clearance after IV administration

Pharmacokinetic parameter - Apparent clearance

Time frame · Day 0 to Day 73

CL/F for subcutaneous doses

Pharmacokinetic parameter - Volume of distribution

Time frame · Day 0- Day 22

Volume of distribution after IV dosing

Pharmacokinetic parameter - apparent volume of distribution

Time frame · Day 0 to Day 73

Vss/F and Vz/F for subcutaneous doses

Secondary outcomes

Pharmacokinetic parameter - Cmax

Time frame · Day 0 to Day 73

Maximum observed plasma concentration

Pharmacokinetic parameter - tmax

Time frame · Day 0 to Day 73

time of maximum observed plasma concentration

Pharmacokinetic parameter - AUC

Time frame · Day 0 to Day 73

Area under the curve

Pharmacodynamic parameter - plasma citrulline levels

Time frame · Day 0 to Day 73

change in plasma citrulline levels

ADA incidence

Time frame · Day 0 to Day 73

Overall incidence of anti-glepaglutide antibodies

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

Safety and tolerability - ECGs

Time frame · Day 0 to Day 73

12 lead electrocardiogram parameters

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
60 Years
Sex
ALL
Healthy volunteers
Yes

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.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Covance CRU

Dallas, Texas, United States

Related trials

More studies on Glepaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.