Current partner codePEPTIDESDE
PeptideStat
Menu

Vendors

Compare pricesVendor directoryVendor reviewsDiscount codesLab tests & COAs

Research

ResearchDatabaseClinical trials

Tools

All calculatorsReconstitutionAccumulationUnit converterPeptide chemistry
NCT02012556·Phase 1·INTERVENTIONAL

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

TesamorelinOtherCompleted

Status

Completed

Phase

Phase 1

Enrollment

18

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Tesamorelin

Timeline

From registration to results.

  1. First posted

    Dec 16, 2013

  2. Study start

    May 2008

  3. Primary completion

    Jul 2008

  4. Study completion

    Jul 2008

  5. Results posted

    Not reported

  6. Registry updated

    Dec 16, 2013

Outcomes

What the study measures.

Primary outcomes

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.

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.

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.

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.

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.

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.

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

Time frame · Day 1.

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

Time frame · Day 7.

Secondary outcomes

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

Time frame · 14 days

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
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.

Study locations

1 registered sites.

Canada. Showing up to 24 locations stored in the fast local snapshot.

Anapharm Montreal

Montreal, Quebec, Canada

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Tesamorelin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsTesamorelin trial dashboard →DatabaseTesamorelin database entry →MarketTesamorelin comparison →Research vendor recordAscension Peptides →Research vendor recordNura Peptide →Research vendor recordGlacier Aminos →Research vendor recordEZ Peptides →Research vendor recordNOVA Labs →