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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05096598
Other study ID # ZP8396-21037
Secondary ID 2021-001712-28U1
Status Completed
Phase Phase 1
First received
Last updated
Start date October 19, 2021
Est. completion date January 12, 2023

Study information

Verified date January 2023
Source Zealand Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The research study will investigate the safety and tolerability of ZP8396 in healthy study participants. In addition, the study will investigate how ZP8396 works in the body (pharmacokinetics and pharmacodynamics). Participants will receive 1 single dose either as an injection under the skin (subcutaneous, s.c.) or an injection into a vein of one arm (intravenous, i.v.). Participants will have 9 visits with the study team. One of these visits consists of 8 overnight stays at the study site. For each participant, the study will last up to 66 days.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date January 12, 2023
Est. primary completion date January 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Healthy male subject - Body Mass Index (BMI) between 21.0 and 29.9 kg/m^2, both inclusive - Body weight of at least 70.0 kg - Glycosylated hemoglobin A1c (HbA1c) less than 5.7 percent - Further inclusion criteria apply Exclusion Criteria: - History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke - Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure less than 50 mmHg or greater than 89 mmHg - Symptoms of arterial hypotension - Further exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ZP8396
Participants will receive 1 single dose of ZP8396 given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm). Dose level will depend on the cohort.
Placebo (ZP8396)
Participants will receive 1 single dose of placebo given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm).

Locations

Country Name City State
Germany Profil Institut für Stoffwechselforschung GmbH Neuss North Rhine-Westphalia

Sponsors (1)

Lead Sponsor Collaborator
Zealand Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of treatment emergent adverse events (TEAEs) From dosing (Day 1) to end of trial (Day 50)
Secondary Pharmacokinetics (PK) of ZP8396 (AUCt) Area under the plasma concentration-time curve over a dosing interval Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Secondary Pharmacokinetics (PK) of ZP8396 (AUCinf) Area under the plasma concentration-time curve from time zero to infinity Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Secondary Pharmacokinetics (PK) of ZP8396 (AUClast) Area under the plasma concentration-time curve from time zero to the time of the last measurable concentration Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Secondary Pharmacokinetics (PK) of ZP8396 (Cmax) Maximum (peak) plasma drug concentration Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Secondary Pharmacokinetics (PK) of ZP8396 (tmax) Time to reach maximum (peak) plasma concentration Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Secondary Pharmacokinetics (PK) of ZP8396 (?z) Elimination rate constant Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Secondary Pharmacokinetics (PK) of ZP8396 (t½) Elimination half-life Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Secondary Pharmacokinetics (PK) of ZP8396 (Vz/f) Apparent volume of distribution during terminal phase Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Secondary Pharmacokinetics (PK) of ZP8396 (Vz) Volume of distribution during the terminal phase (i.v. only) Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Secondary Pharmacokinetics (PK) of ZP8396 (CL/f) Apparent total clearance of the drug from plasma Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Secondary Pharmacokinetics (PK) of ZP8396 (CL) Total body clearance of the drug (i.v. only) Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Secondary Pharmacokinetics (PK) of ZP8396 (MRT) Mean residence time Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Secondary Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax acetaminophen) Maximum acetaminophen concentration after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Secondary Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax acetaminophen) Time to maximum acetaminophen concentration after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Secondary Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-60 min) Area under the acetaminophen concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Secondary Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-240 min) Area under the acetaminophen concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Secondary Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, Plasma Glucose [PG]) Maximum PG concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Secondary Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, Plasma Glucose [PG]) Time to maximum PG concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Secondary Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-60 min) Area under the Plasma Glucose (PG) concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Secondary Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-240 min) Area under the Plasma Glucose (PG) concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Secondary Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, insulin) Maximum insulin concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Secondary Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, insulin) Time to maximum insulin concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Secondary Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCinsulin,0-60 min) Area under the insulin concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Secondary Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCinsulin,0-240 min) Area under the insulin concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Secondary Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, glucagon) Maximum glucagon concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Secondary Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, glucagon) Time to maximum glucagon concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Secondary Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCglucagon,0-60 min) Area under the glucagon concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Secondary Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCglucagon,0-240 min) Area under the glucagon concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
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