Male Hypogonadism
Conditions
Keywords
Primary hypogonadism, Secondary hypogonadism
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 initiation of the meal.
Interventions
DRUGOral testosterone undecanoate (containing 300 mg T)
Sponsors
Clarus Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet | 25 hour serial blood draws separated by 4 to 10 days of washout between treatments. | 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. |
Countries
Canada, United States
Participant flow
Recruitment details
Sixteen subjects (8 at each study center) were enrolled. A total of 72 subjects were screened (16 subjects at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and 56 subjects were screened at Anapharm, beginning on April 3, 2009.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state (Treatment A) and followed by a dose-associated breakfast meal comprised of \
800 calories consisting of very low fat (6-10% fat, Treatment B), low fat (20% fat, Treatment C), normal diet (30% fat, Treatment D) and high fat (50% fat, Treatment E). Participants were randomized to one of the 4 treatment sequences (ABCDE, BDCEA, CBEDA, OR DBAEC).
Oral testosterone undecanoate (containing 300 mg T) | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 14 |
| BMI | 30.1 kg/m^2 STANDARD_DEVIATION 4.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 174.1 centimeters STANDARD_DEVIATION 7.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment Canada | 8 participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 16 Participants |
| Weight | 91.1 kilograms STANDARD_DEVIATION 14.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 2 / 16 | 0 / 16 | 2 / 16 | 4 / 16 | 3 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
Outcome results
Primary
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.
Time frame: 25 hour serial blood draws separated by 4 to 10 days of washout between treatments.
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Fasting | Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet | 6.38 ng/dL | Standard Deviation 0.456 |
| Very Low Fat Diet | Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet | 6.73 ng/dL | Standard Deviation 0.41 |
| Low Fat Diet | Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet | 6.88 ng/dL | Standard Deviation 0.356 |
| Normal Diet | Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet | 7.00 ng/dL | Standard Deviation 0.264 |
| High Fat Diet | Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet | 7.18 ng/dL | Standard Deviation 0.312 |
Comparison: Comparison of diets based on full crossover modelp-value: 0.002590% CI: [113.59, 150.7]t-test, 2 sided
Comparison: Comparison of diets based on full crossover modelp-value: 0.849490% CI: [86.8, 119.47]t-test, 2 sided
Comparison: Comparison of diets based on full crossover modelp-value: 0.001390% CI: [63.23, 85.55]t-test, 2 sided
Comparison: Comparison of diets based on full crossover modelp-value: <0.000190% CI: [53.38, 76.46]t-test, 2 sided