drugset / Trial / NCT02012556

Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients

NCT02012556

Phase 1 Completed 18 enrolled Theratechnologies
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of the study is to determine the PK (tesamorelin) and PD (IGF-1) profiles of tesamorelin after a single 2 mg subcutaneous administration and after repeated administration once daily for 14 consecutive days. Secondary objectives include the evaluation of the safety and tolerability of tesamorelin following multiple subcutaneous injections.

Timeline

Start
2008-05
Primary completion
2008-07
Completion
2008-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Tesamorelin Peptide 2 mg Subcutaneous