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A Phase 1/2a Study to Determine the Dose Response Pharmacokinetics of TSX-011 (Testosterone Undecanoate) in Hypogonadal Males

NCT03335254 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-05-16

Study results available
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Summary

This will be a phase 1/2a, open-label, single-center study with 3 periods. The aims of the study are to:

1. evaluate the dose-response curve following ascending single doses of TSX-011;
2. confirm optimum dosing conditions;
3. evaluate the efficacy of single or multiple daily adaptive dosing; and
4. evaluate the safety and tolerability of TSX-011.

Conditions

  • Hypogonadism
  • Hypogonadism, Male
  • Gonadal Disorders
  • Endocrine System Diseases
  • Testosterone Deficiency

Interventions

DRUG

TSX-011

TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Sponsors & Collaborators

  • TesoRx Pharma, LLC

    lead INDUSTRY

Principal Investigators

  • Michael Oefelein, MD · TesoRx Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-06
Primary Completion
2018-05-03
Completion
2018-05-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03335254 on ClinicalTrials.gov