Current partner codePEPTIDESDE
NCT04318743·Phase 1·INTERVENTIONAL

A Bridging Trial to Compare the PK Profile When Glepaglutide is Administered Via Vial/Syringe Versus Autoinjector.

Status

Completed

Phase

Phase 1

Enrollment

85

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This is an open-label, randomized, single center, 2-treatment, 3-period, 3-sequence reference-replicated, crossover trial in healthy subjects to compare the PK of glepaglutide (ZP1848) after a single SC administration by vial/syringe and by autoinjector.

Full detailed description

A total of 72 subjects will be randomized in a 1:1:1 ratio to receive 10 mg glepaglutide SC via vial/syringe (Reference) twice or autoinjector (Test) in one of the 3 treatment sequences.

Interventions

Treatment arms and agents.

DRUG

Glepaglutide

GLP-2

Timeline

From registration to results.

  1. First posted

    Mar 24, 2020

  2. Study start

    Mar 4, 2020

  3. Primary completion

    Jun 10, 2021

  4. Study completion

    Jun 10, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Jul 14, 2021

Outcomes

What the study measures.

Primary outcomes

Pharmacokinetic Variables

Time frame · From time zero to the last time point with a measurable concentration

Cmax = maximum concentration of ZP1848total in plasma

Pharmacokinetic Variables

Time frame · from time zero to the last time point with a measurable concentration

AUC0-t = area under the plasma ZP1848total concentration-time curve (AUC)

Secondary outcomes

Safety Variables

Time frame · 16 weeks

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

Eligibility

Who can take part.

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

Inclusion Criteria: 1. Informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject). 2. Healthy male or female subject aged between 18 years and 54 years, both inclusive, at screening. 3. Body mass index (BMI) \>20.0 kg/m2 and \<29.9 kg/m2, both inclusive, at screening. 4. Willing to maintain a stable weight for the duration of the trial. 5. In overall good health according to age (medical history, physical examination, vital signs, and laboratory assessments), as judged by the Investigator at screening. 6. Able to comply with all trial procedures. Exclusion Criteria: 1. Significant medical history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator. 2. Subject with a history of colon cancer or a history of other cancers within the last 5 years. 3. Clinically significant abnormality from physical examination, standard 12-lead ECG, or vital signs measurements as determined by the Investigator. 4. Clinically significant abnormality in hematology, clinical chemistry, or urinalysis as determined by the Investigator (congenital nonhemolytic hyperbilirubinemia \[eg, Gilbert's syndrome\] is acceptable). 5. History of significant hypersensitivity, intolerance, suspected hypersensitivity to glepaglutide or related products, or allergy to any drug compound, food, or other substance, unless approved by the Investigator. 6. Positive results for hepatitis B surface antigens (HbsAg), hepatitis C virus (HCV) antibodies and/or human immunodeficiency virus (HIV) 1 antigen or HIV 1/2 antibodies, at screening. 7. Receipt of blood products within 2 months prior to screening. 8. Donation of blood or significant blood loss from 8 weeks prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening. 9. Use of any prescription medications/products (other than oral, implantable, transdermal, injectable, or intrauterine hormonal contraceptives) within 14 days prior to screening, unless deemed acceptable by the Investigator. 10. Use of any nonprescription, over-the-counter medication/products, including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations, within 7 days prior to screening unless deemed acceptable by the Investigator. Up to 2 grams per day of acetaminophen is allowed at the discretion of the Investigator. 11. Use of any medications/products known to be strong inhibitors or strong inducers of cytochrome P450 3A enzyme, including St. John's wort, within 30 days prior to screening, unless deemed acceptable by the Investigator. 12. Have previously received the investigational product. 13. Receipt of any investigational product within 60 days prior to screening. Participation in more than 3 other drug studies in the 10 months prior to screening in the current trial. 14. Previous exposure to glucagon-like peptide-1 (GLP-1), GLP-2, or analogs thereof. Previous exposure to human growth hormone, somatostatin, dipeptidyl peptidase-4 inhibitors, or analogs thereof within 6 months prior to screening. 15. Have previously completed or withdrawn from this trial or any other trial investigating glepaglutide. 16. History of alcoholism or drug/chemical abuse within 2 years prior to screening. 17. Current alcohol consumption of \>21 units per week for males and \>14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL wine). 18. Positive urine drug screen (confirmed by repeat). 19. 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. 20. Poor peripheral venous access. 21. Positive qualitative serum pregnancy test (serum human chorionic gonadotropin) (female subjects only). 22. Female who is pregnant, breastfeeding, intends to become pregnant in the immediate future. 23. Female subject of childbearing potential who is sexually active without using adequate contraceptive methods (see Section 3.4.8) from 4 weeks prior to first admission to the clinical research center until 3 months after the last dose of trial product.\* 24. Male subject, who is not surgically sterilized and sexually active with a female partner of childbearing potential, and who is not willing to use adequate contraceptive methods (see Section 3.4.8), from the first dosing until 3 months after the last dose of trial product. 25. Subjects whom, in the opinion of the Investigator, should not participate in this trial. 26. Employee of PRA or the Sponsor or otherwise dependent. \* Participant is of nonchildbearing potential, if she is either surgically sterilized (ie, by tubal ligation or removal of ovaries), has undergone complete hysterectomy, or is in a menopausal state (ie, at least one year without menses and a serum follicle-stimulating hormone \[FSH\] \>40 IU/L at screening).

Study locations

1 registered sites.

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

PRA Health Sciences- Location Martini

Groningen, NZ, Netherlands

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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.