Status:
COMPLETED
Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation
Lead Sponsor:
Clarus Therapeutics, Inc.
Conditions:
Male Hypogonadism
Eligibility:
MALE
18-65 years
Phase:
PHASE2
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.
Detailed Description
Pharmacokinetics will be evaluated after the following types of meals: very low fat, low fat, normal diet, high fat, and fasting. Subjects will have one dose of TU administered 30 minutes after the in...
Eligibility Criteria
Inclusion
- Male
- Age 18-65
- Morning serum testosterone (T) \<300 ng/dL on two occasions
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00924612
Start Date
July 1 2009
End Date
July 1 2010
Last Update
December 2 2020
Active Locations (2)
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1
LABiomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
2
Anapharm, Inc.
Québec, Quebec, Canada, G1P 0A2