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

HIV Clinical Trial

Official title:

A Phase 1 Study to Evaluate the Pharmacokinetics and the Pharmacodynamics of TH9507 Administered Subcutaneously Once Daily for 14 Consecutive Days in HIV Positive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012556
• Other study ID #: TH9507-CTR-1015
• Status: Completed
• Phase: Phase 1
• First received: November 26, 2013
• Last updated: December 10, 2013
• Start date: May 2008
• Est. completion date: July 2008

Study information

• Verified date: December 2013
• Source: Theratechnologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Main Inclusion Criteria:

• Male or female, smoker or non-smoker, =18 and =65 years of age.

• HIV-positive with CD4 cell counts >100 cells/mm3 and viral load <10 000 copies/mL.

• On stable antiretroviral therapy (ART) regimen for at least 8 weeks prior to the first study drug administration.

• Body mass index (BMI) = 20.0 kg/m2.

Main Exclusion Criteria:

• Opportunistic infection or HIV-related disease within 3 months prior to study drug administration.

• History of malignancy of any organ or tissue (with the exception of basal cell carcinoma of the skin, in situ carcinoma of the cervix and stable Kaposi not having required treatment for the past 6 months).

• For male subjects, suspicion of prostate cancer.

• For female subjects, history of breast cancer or strong family history (first degree relative) of breast cancer.

• Known hypopituitarism, history of pituitary tumor/surgery, head irradiation or severe head trauma that had affected the somatotropic axis.

• Use of any experimental or marketed GH or GRF/GHRH products, GH secretagogues, IGF-1, or insulin-like growth factor binding protein-3 (IGFBP-3) within 6 months prior to study drug administration and throughout the study.

• Positive pregnancy test at screening.

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• Tesamorelin

Locations

Country	Name	City	State
Canada	Anapharm Montreal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Theratechnologies

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the Plasma Concentration versus Time Curve (AUC) of Tesamorelin.		Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14.	No
Primary	Peak Plasma Concentration (Cmax) of Tesamorelin.		Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14.	No
Primary	Time to Maximum Plasma Concentration (Tmax) of Tesamorelin.		Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14.	No
Primary	Apparent Elimination Half-life (T1/2 el) of Tesamorelin.		Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14.	No
Primary	Plasma Clearance (CI/F) of Tesamorelin.		Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14.	No
Primary	Apparent Volume of Distribution (Vd/F) of Tesamorelin.		Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14.	No
Primary	Insulin-like Growth Factor-1 (IGF-1) Level at Day 1.		Day 1.	No
Primary	Insulin-like Growth Factor-1 (IGF-1) Level at Day 7		Day 7.	No
Primary	Insulin-like Growth Factor-1 (IGF-1) Level at Day 13.		Day 13.	No
Primary	Insulin-like Growth Factor-1 (IGF-1) Level at Day 14.		Day 14.	No
Secondary	Number of Subjects with Adverse Events as a Measure of Safety and Tolerability		14 days	Yes