Back to resultsPharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients
Primary Purpose
HIV
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Tesamorelin
Sponsored by
About this trial
This is an interventional treatment trial for HIV
Eligibility Criteria
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.
Sites / Locations
- Anapharm Montreal
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tesamorelin
Arm Description
Outcomes
Primary Outcome Measures
Area under the Plasma Concentration versus Time Curve (AUC) of Tesamorelin.
Peak Plasma Concentration (Cmax) of Tesamorelin.
Time to Maximum Plasma Concentration (Tmax) of Tesamorelin.
Apparent Elimination Half-life (T1/2 el) of Tesamorelin.
Plasma Clearance (CI/F) of Tesamorelin.
Apparent Volume of Distribution (Vd/F) of Tesamorelin.
Insulin-like Growth Factor-1 (IGF-1) Level at Day 1.
Insulin-like Growth Factor-1 (IGF-1) Level at Day 7
Insulin-like Growth Factor-1 (IGF-1) Level at Day 13.
Insulin-like Growth Factor-1 (IGF-1) Level at Day 14.
Secondary Outcome Measures
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02012556
Brief Title
Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients
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 Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theratechnologies
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tesamorelin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tesamorelin
Other Intervention Name(s)
Egrifta
Primary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
Insulin-like Growth Factor-1 (IGF-1) Level at Day 1.
Time Frame
Day 1.
Title
Insulin-like Growth Factor-1 (IGF-1) Level at Day 7
Time Frame
Day 7.
Title
Insulin-like Growth Factor-1 (IGF-1) Level at Day 13.
Time Frame
Day 13.
Title
Insulin-like Growth Factor-1 (IGF-1) Level at Day 14.
Time Frame
Day 14.
Secondary Outcome Measure Information:
Title
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Larouche, MD
Organizational Affiliation
Anapharm
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anapharm Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3X 2H9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients
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