Trial record 4 of 33 for:    " November 20, 2013":" December 20, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theratechnologies
ClinicalTrials.gov Identifier:
NCT02012556
First received: November 26, 2013
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
HIV
Drug: Tesamorelin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Theratechnologies:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Insulin-like Growth Factor-1 (IGF-1) Level at Day 1. [ Time Frame: Day 1. ] [ Designated as safety issue: No ]
  • Insulin-like Growth Factor-1 (IGF-1) Level at Day 7 [ Time Frame: Day 7. ] [ Designated as safety issue: No ]
  • Insulin-like Growth Factor-1 (IGF-1) Level at Day 13. [ Time Frame: Day 13. ] [ Designated as safety issue: No ]
  • Insulin-like Growth Factor-1 (IGF-1) Level at Day 14. [ Time Frame: Day 14. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Subjects with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: May 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tesamorelin Drug: Tesamorelin
Other Name: Egrifta

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02012556

Locations
Canada, Quebec
Anapharm Montreal
Montreal, Quebec, Canada, H3X 2H9
Sponsors and Collaborators
Theratechnologies
Investigators
Principal Investigator: Richard Larouche, MD Anapharm
  More Information

No publications provided

Responsible Party: Theratechnologies
ClinicalTrials.gov Identifier: NCT02012556     History of Changes
Other Study ID Numbers: TH9507-CTR-1015
Study First Received: November 26, 2013
Last Updated: December 10, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Growth Hormone-Releasing Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014