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

December 10, 2013 updated by: Theratechnologies

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tesamorelin
Drug: Tesamorelin
Other Names:
  • Egrifta

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time Frame: Day 1.
Day 1.
Insulin-like Growth Factor-1 (IGF-1) Level at Day 7
Time Frame: Day 7.
Day 7.
Insulin-like Growth Factor-1 (IGF-1) Level at Day 13.
Time Frame: Day 13.
Day 13.
Insulin-like Growth Factor-1 (IGF-1) Level at Day 14.
Time Frame: Day 14.
Day 14.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Theratechnologies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard Larouche, MD, Anapharm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TH9507-CTR-1015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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