A Bridging Trial to Compare the PK Profile When Glepaglutide is Administered Via Vial/Syringe Versus Autoinjector.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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 Design
Arms and Interventions
| 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:
|
| Experimental: vial/syringe - autoinjector - vial/syringe Single dose of Glepaglutide 10 mg for each treatment sequence |
Drug: Glepaglutide
GLP-2
Other Names:
|
| Experimental: vial/syringe - vial/syringe - autoinjector Single dose of Glepaglutide 10 mg for each treatment sequence |
Drug: Glepaglutide
GLP-2
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetic Variables [From time zero to the last time point with a measurable concentration]
Cmax = maximum concentration of ZP1848total in plasma
- Pharmacokinetic Variables [from time zero to the last time point with a measurable concentration]
AUC0-t = area under the plasma ZP1848total concentration-time curve (AUC)
Secondary Outcome Measures
- Safety Variables [16 weeks]
Number of subject with AE/SAE as a measure of safety and tolerability
Eligibility Criteria
Criteria
Inclusion Criteria:
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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).
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Healthy male or female subject aged between 18 years and 54 years, both inclusive, at screening.
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Body mass index (BMI) >20.0 kg/m2 and <29.9 kg/m2, both inclusive, at screening.
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Willing to maintain a stable weight for the duration of the trial.
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In overall good health according to age (medical history, physical examination, vital signs, and laboratory assessments), as judged by the Investigator at screening.
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Able to comply with all trial procedures.
Exclusion Criteria:
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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.
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Subject with a history of colon cancer or a history of other cancers within the last 5 years.
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Clinically significant abnormality from physical examination, standard 12-lead ECG, or vital signs measurements as determined by the Investigator.
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Clinically significant abnormality in hematology, clinical chemistry, or urinalysis as determined by the Investigator (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is acceptable).
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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.
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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.
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Receipt of blood products within 2 months prior to screening.
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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.
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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.
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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.
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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.
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Have previously received the investigational product.
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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.
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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.
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Have previously completed or withdrawn from this trial or any other trial investigating glepaglutide.
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History of alcoholism or drug/chemical abuse within 2 years prior to screening.
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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).
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Positive urine drug screen (confirmed by repeat).
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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.
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Poor peripheral venous access.
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Positive qualitative serum pregnancy test (serum human chorionic gonadotropin) (female subjects only).
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Female who is pregnant, breastfeeding, intends to become pregnant in the immediate future.
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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.*
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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.
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Subjects whom, in the opinion of the Investigator, should not participate in this trial.
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | PRA Health Sciences- Location Martini | Groningen | NZ | Netherlands | 9728 |
Sponsors and Collaborators
- Zealand Pharma
Investigators
- Study Director: Stine Just Maarbjerg, PhD, Zealand Pharma A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZP1848-19045