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

Sponsor
Theratechnologies (Industry)
Overall Status
Completed
CT.gov ID
NCT02012556
Collaborator
(none)
18
Enrollment
1
Location
1
Arm
2
Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
May 1, 2008
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Jul 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tesamorelin

Drug: Tesamorelin
Other Names:
  • Egrifta

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.]

    2. 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.]

    3. 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.]

    4. 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.]

    5. 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.]

    6. 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.]

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

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

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

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

    Secondary Outcome Measures

    1. Number of Subjects with Adverse Events as a Measure of Safety and Tolerability [14 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anapharm Montreal Montreal Quebec Canada H3X 2H9

    Sponsors and Collaborators

    • Theratechnologies

    Investigators

    • Principal Investigator: Richard Larouche, MD, Anapharm

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Theratechnologies
    ClinicalTrials.gov Identifier:
    NCT02012556
    Other Study ID Numbers:
    • TH9507-CTR-1015
    First Posted:
    Dec 16, 2013
    Last Update Posted:
    Dec 16, 2013
    Last Verified:
    Dec 1, 2013
    Additional relevant MeSH terms:
    HIV Seropositivity
    Tesamorelin

    Study Results

    No Results Posted as of Dec 16, 2013