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Completed

NCT Number: NCT02012556

Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, 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.

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Key information

Conditions

HIV

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anapharm Montreal

Montreal, Quebec, H3X 2H9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tesamorelin

Drug

Other names: Egrifta

Primary outcomes

  1. Area under the Plasma Concentration versus Time Curve (AUC) of Tesamorelin.

    Time frame: 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.

  2. Peak Plasma Concentration (Cmax) of Tesamorelin.

    Time frame: 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.

  3. Time to Maximum Plasma Concentration (Tmax) of Tesamorelin.

    Time frame: 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.

  4. Apparent Elimination Half-life (T1/2 el) of Tesamorelin.

    Time frame: 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.

  5. Plasma Clearance (CI/F) of Tesamorelin.

    Time frame: 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.

  6. Apparent Volume of Distribution (Vd/F) of Tesamorelin.

    Time frame: 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.

  7. Insulin-like Growth Factor-1 (IGF-1) Level at Day 1.

    Time frame: Day 1.

  8. Insulin-like Growth Factor-1 (IGF-1) Level at Day 7

    Time frame: Day 7.

  9. Insulin-like Growth Factor-1 (IGF-1) Level at Day 13.

    Time frame: Day 13.

  10. Insulin-like Growth Factor-1 (IGF-1) Level at Day 14.

    Time frame: Day 14.

Secondary outcomes

  1. Number of Subjects with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Theratechnologies

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Dec 16, 2013
Registry last updated
Dec 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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