A Phase 1 interventional study of P7435 and Placebo in Healthy, sponsored by Piramal Enterprises Limited. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-26.
Sponsored by Piramal Enterprises Limited · Phase 1 and Interventional
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 100 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Piramal Enterprises Limited is the lead sponsor of 23 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* In Part A, there will be up to 6 cohorts of 8 subjects each (for the 2 cohorts undergoing food effect study, there will be 12 subjects in each cohort). At each dose level, every subject will participate in two periods (one with active, P7435 and the second period with matching placebo or vice versa) separated by appropriate wash-out period between the two periods. The randomization scheme will ensure that no subject undergoes the placebo period twice. * In Part B, there will be up to 3 cohorts of 10 subjects each. Each of the 3 cohorts will participate in two study periods of 10 days of dosing in each (one period with active, P7435 and the other period with matching placebo or vice versa) separated by appropriate wash-out period.
Drug: P7435
* In Part A, there will be up to 6 cohorts of 8 subjects each (for the 2 cohorts undergoing food effect study, there will be 12 subjects in each cohort). At each dose level, every subject will participate in two periods (one with active, P7435 and the second period with matching placebo or vice versa) separated by appropriate wash-out period between the two periods. The randomization scheme will ensure that no subject undergoes the placebo period twice. * In Part B, there will be up to 3 cohorts of 10 subjects each. Each of the 3 cohorts will participate in two study periods of 10 days of dosing in each (one period with active, P7435 and the other period with matching placebo or vice versa) separated by appropriate wash-out period.
Other: Placebo
Number of participants with adverse events (single and multiple dose studies)
- To determine the safety and tolerability of single (Part A) and multiple (Part B) ascending doses of P7435 in healthy, overweight or obese subjects
Time frame: 12-14 Months
Food Effect
* To determine the effect of food on the pharmacokinetics (PK) of P7435 following single oral doses in these subjects (Part A) * The pharmacokinetic parameters (but not limited to) calculated in the double-blind active period (fed) versus the open-label active period (fasted) will be considered for the determination of the food effect. * The following parameters will be calculated: Cmax, tmax, tlag, AUC0-t, AUC0-inf, %AUC extrapolated, AUC0-24, kel, t½ for each of the periods i.e., fasted versus fed.
Time frame: 12-14 Months
Area under the plasma concentration (AUC)
Part A: The PK profile will be derived from the P7435 plasma concentration data on Day 1. Part B: The PK profile will be derived from the P7435 plasma concentration data on Days 1 and 10. Trough levels will be compared to assess steady state.
Time frame: 12- 14 Months
Peak Plasma concentration (Cmax)
Part A: The PK profile will be derived from the P7435 plasma concentration data on Day 1. Part B: The PK profile will be derived from the P7435 plasma concentration data on Days 1 and 10. Trough levels will be compared to assess steady state.
Time frame: 12- 14 Months
Time to peak plasma concentration (t-max)
Part A: The PK profile will be derived from the P7435 plasma concentration data on Day 1. Part B: The PK profile will be derived from the P7435 plasma concentration data on Days 1 and 10. Trough levels will be compared to assess steady state.
Time frame: 12- 14 Months
Change in Fasting serum lipids
- Fasting serum lipids \[total cholesterol, triglycerides, low-density lipoproteins (LDL C), high-density lipoproteins (HDL-C), very-low-density lipoproteins (VLDL), free fatty acids and apolipoprotein-B (Apo-B)\] (Part B only)
Time frame: 12- 14 Month
Change in Fasting plasma glucose
Part B only
Time frame: 12- 14 Months
Fat tolerance test
- Fat tolerance test variables including peak and post-prandial glucose, insulin, C peptide, lipids, GLP-1 and GIP and inflammatory biomarkers such as malondialdehyde and β-hydroxy butyrate (Part A and B)
Time frame: 12- 14 month
Fasting serum insulin
Part B only
Time frame: 12 - 14 months
Fasting serum C-peptide
Part B only
Time frame: 12-14 months
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Piramal Enterprises Limited