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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT02012556 (opens ClinicalTrials.gov in a new tab)Other idTH9507-CTR-1015
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Overview

Status
Completed
Phase
Phase 1
Enrollment
18 participants (actual)
Sponsor
Theratechnologies · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Canada

Start
May 2008
Primary completion
Jul 2008
Completion
Jul 2008
First posted
16 Dec 2013 (estimated)
Last update posted
16 Dec 2013 (estimated)
Conditions
HIV

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082009
  1. Ph 1

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

    NCT02012556

    May 2008 to Jul 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TesamorelinDrug

Arms1

  • Experimental

    Tesamorelin

Primary outcomes10

Outcomes the sponsor listed as primary.

  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)

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

    Time frame · 14 days

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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