Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation

NCT00924612 | Completed Phase 2 Results

• 1 other identifier: CLAR-09008
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.

Conditions

Male Hypogonadism

Keywords

Primary hypogonadism; Secondary hypogonadism

Outcome Measures

Primary Outcomes (1)

• Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet

  PK population where subjects are randomly assigned to one of four dietary sequences of five fat regimens. Active drug is identical for all subjects and all diets. Effect of normal dietary fat is compared to fasting, very low fat, low fat, and high fat diets for mean T Cavg25.

  25 hour serial blood draws separated by 4 to 10 days of washout between treatments.

Study Arms (5)

Fasting (Treatment A)

EXPERIMENTAL

Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state

Drug: Oral testosterone undecanoate (containing 300 mg T)

Very low fat diet (Treatment B)

EXPERIMENTAL

Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with very low fat (6-10% fat).

Drug: Oral testosterone undecanoate (containing 300 mg T)

Low fat diet (Treatment C)

EXPERIMENTAL

Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with low fat (20% fat).

Drug: Oral testosterone undecanoate (containing 300 mg T)

Normal diet (Treatment D)

EXPERIMENTAL

Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with normal fat (30% fat).

Drug: Oral testosterone undecanoate (containing 300 mg T)

High fat diet (Treatment E)

EXPERIMENTAL

Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with high fat (50% fat).

Drug: Oral testosterone undecanoate (containing 300 mg T)

Interventions

Oral testosterone undecanoate (containing 300 mg T) DRUG

Fasting (Treatment A); High fat diet (Treatment E); Low fat diet (Treatment C); Normal diet (Treatment D); Very low fat diet (Treatment B)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• Age 18-65
• Morning serum testosterone (T) \<300 ng/dL on two occasions

You may not qualify if:

• Significant intercurrent disease
• Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score \>15 or history of prostate cancer.
• Serum transaminases \>2 times upper limit of normal
• Serum bilirubin \>2.0 mg/dL
• Hematocrit \<35% or \>50%
• BMI \>36
• Untreated, obstructive sleep apnea.

Sponsors & Collaborators

• Clarus Therapeutics, Inc.: lead

Study Sites (2)

LABiomedical Research Institute at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Anapharm, Inc.

Québec, Quebec, G1P 0A2, Canada

Location

MeSH Terms

Conditions

Eunuchism; Hypogonadism

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Robert E. Dudley, PhD, CEO and President
• Organization: Clarus Therapeutics, Inc.

rdudley@clarustherapeutics.com

847-562-4300

Study Officials

• Ronald Swerdloff, MD

  LABiomedical Research Institute at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, five-period, randomized, four-sequence (ABCDE, BDCEA,CBEDA, DBAEC), cross-over study to determine the effect of food containing various amounts of dietary fat on the pharmacokinetics of oral TU.

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 19, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: July 1, 2010
• Last Updated: December 2, 2020
• Results First Posted: December 2, 2020

Record last verified: 2020-11

Locations

CA (1); US (1)