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

A Bridging Trial to Compare the Pharmacokinetics of Glepaglutide (ZP1848) After Single Subcutaneous Adminstration by Vial/Syringe and by Autoinjector in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Glepaglutide

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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • NZ
    • Groningen, NZ, Netherlands, 9728
      • PRA Health Sciences- Location Martini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 54 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: autoinjector - vial/syringe - vial/syringe; Single dose of Glepaglutide 10 mg for each treatment sequence	Drug: Glepaglutide; GLP-2; Other Names: ZP1848
EXPERIMENTAL: vial/syringe - autoinjector - vial/syringe; Single dose of Glepaglutide 10 mg for each treatment sequence	Drug: Glepaglutide; GLP-2; Other Names: ZP1848
EXPERIMENTAL: vial/syringe - vial/syringe - autoinjector; Single dose of Glepaglutide 10 mg for each treatment sequence	Drug: Glepaglutide; GLP-2; Other Names: ZP1848

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Variables	Cmax = maximum concentration of ZP1848total in plasma	From time zero to the last time point with a measurable concentration
Pharmacokinetic Variables	AUC0-t = area under the plasma ZP1848total concentration-time curve (AUC)	from time zero to the last time point with a measurable concentration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Variables	Number of subject with AE/SAE as a measure of safety and tolerability	16 weeks

Collaborators and Investigators

• Sponsor: Zealand Pharma
• Investigators: Study Director: Stine Just Maarbjerg, PhD, Zealand Pharma A/S

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 4, 2020
• Primary Completion (ACTUAL): June 10, 2021
• Study Completion (ACTUAL): June 10, 2021

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (ACTUAL): March 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ZP1848-19045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No