A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE I STUDY TO DETERMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SINGLE ASCENDING ORAL DOSES OF P1201-07 IN HEALTHY OVERWEIGHT OR OBESE SUBJECTS

Completed

• Conditions: Obesity; overweight; 10003018

• Registration Number: NL-OMON32187
• Lead Sponsor: icholas Piramal India Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

18-55 year of age for males
18-65 year of age for females

Exclusion Criteria

* Regular treatment with non-topical medications within 90 days prior to drug administration.
* History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
* Use of concomitant medication including sedatives and steroids, except for paracetamol, at least 14 days prior to the first dose

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>AEs, vital signs, ECG-parameters, laboratory parameters, physical parameters</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Plasma P1201-07 concentrations, pharmacokinetic parameters: Cmax, tmax, AUC0-t,<br /><br>AUC0-inf, %AUC, kel, t*, CL, Vz</p><br>