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

Clarus Therapeutics

Status and phase: Completed; Phase 2

Conditions: Male Hypogonadism

Treatments: Drug: Oral testosterone undecanoate (containing 300 mg T)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00924612

CLAR-09008

Details and patient eligibility

About

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.

Full 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 initiation of the meal.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 5 patient groups

Fasting (Treatment A)

Experimental group

Description:

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

Treatment:

Drug: Oral testosterone undecanoate (containing 300 mg T)

Very low fat diet (Treatment B)

Experimental group

Description:

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).

Treatment:

Drug: Oral testosterone undecanoate (containing 300 mg T)

Low fat diet (Treatment C)

Experimental group

Description:

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).

Treatment:

Drug: Oral testosterone undecanoate (containing 300 mg T)

Normal diet (Treatment D)

Experimental group

Description:

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).

Treatment:

Drug: Oral testosterone undecanoate (containing 300 mg T)

High fat diet (Treatment E)

Experimental group

Description:

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).

Treatment:

Drug: Oral testosterone undecanoate (containing 300 mg T)