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

NCT04318743 | Completed Phase 1 FDA Drug

• 1 other identifier: ZP1848-19045
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Safety Variables

  16 weeks

Study Arms (3)

autoinjector - vial/syringe - vial/syringe

EXPERIMENTAL

Single dose of Glepaglutide 10 mg for each treatment sequence

Drug: Glepaglutide

vial/syringe - autoinjector - vial/syringe

EXPERIMENTAL

Single dose of Glepaglutide 10 mg for each treatment sequence

Drug: Glepaglutide

vial/syringe - vial/syringe - autoinjector

EXPERIMENTAL

Single dose of Glepaglutide 10 mg for each treatment sequence

Drug: Glepaglutide

Interventions

Glepaglutide DRUG

GLP-2

Also known as: ZP1848

autoinjector - vial/syringe - vial/syringe; vial/syringe - autoinjector - vial/syringe; vial/syringe - vial/syringe - autoinjector

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• Healthy male or female subject aged between 18 years and 54 years, both inclusive, at screening.
• Body mass index (BMI) \>20.0 kg/m2 and \<29.9 kg/m2, both inclusive, at screening.
• Willing to maintain a stable weight for the duration of the trial.
• In overall good health according to age (medical history, physical examination, vital signs, and laboratory assessments), as judged by the Investigator at screening.
• Able to comply with all trial procedures.

You may not qualify if:

• 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.
• Subject with a history of colon cancer or a history of other cancers within the last 5 years.
• Clinically significant abnormality from physical examination, standard 12-lead ECG, or vital signs measurements as determined by the Investigator.
• Clinically significant abnormality in hematology, clinical chemistry, or urinalysis as determined by the Investigator (congenital nonhemolytic hyperbilirubinemia \[eg, Gilbert's syndrome\] is acceptable).
• 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.
• 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.
• Receipt of blood products within 2 months prior to screening.
• 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.
• 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.
• 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.
• 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.
• Have previously received the investigational product.
• 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.
• 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.
• Have previously completed or withdrawn from this trial or any other trial investigating glepaglutide.

Sponsors & Collaborators

• Zealand Pharma: lead

Study Sites (1)

PRA Health Sciences- Location Martini

Groningen, NZ, 9728, Netherlands

Location

Study Officials

• Stine Just Maarbjerg, PhD

  Zealand Pharma A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: March 4, 2020
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)