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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Drug: Tesamorelin

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3X 2H9
      • Anapharm Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tesamorelin	Drug: Tesamorelin; Other Names: Egrifta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.
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.
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.
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.
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.
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.
Insulin-like Growth Factor-1 (IGF-1) Level at Day 1.	Day 1.
Insulin-like Growth Factor-1 (IGF-1) Level at Day 7	Day 7.
Insulin-like Growth Factor-1 (IGF-1) Level at Day 13.	Day 13.
Insulin-like Growth Factor-1 (IGF-1) Level at Day 14.	Day 14.

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability	14 days

Collaborators and Investigators

• Sponsor: Theratechnologies
• Investigators: Principal Investigator: Richard Larouche, MD, Anapharm

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: November 26, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 16, 2013

Study Record Updates

• Last Update Posted (Estimate): December 16, 2013
• Last Update Submitted That Met QC Criteria: December 10, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; HIV Seropositivity; Physiological Effects of Drugs; Growth Substances; Tesamorelin
• Other Study ID Numbers: TH9507-CTR-1015