Trial Outcomes & Findings for The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate (NCT NCT02921386)
NCT ID: NCT02921386
Last Updated: 2018-05-17
Results Overview
Peak Concentration after morning dose (Cmax) for oral testosterone undecanoate taken after a fasting breakfast of varying fat content.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
0, 1, 2, 3, 4, 6, 8, 12 hours post-dose
Results posted on
2018-05-17
Participant Flow
Participant milestones
| Measure |
Oral Testosterone Undecanoate 237 mg BID
Subjects complete Sequence A-E. Amount of Fat Varies by Sequence. Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to breakfast and immediately prior to dinner.
|
|---|---|
|
Sequence A: Fasting
STARTED
|
18
|
|
Sequence A: Fasting
COMPLETED
|
18
|
|
Sequence A: Fasting
NOT COMPLETED
|
0
|
|
Sequence B: 15 g Fat Breakfast
STARTED
|
18
|
|
Sequence B: 15 g Fat Breakfast
COMPLETED
|
18
|
|
Sequence B: 15 g Fat Breakfast
NOT COMPLETED
|
0
|
|
Sequence C: 30 g Fat Breakfast
STARTED
|
18
|
|
Sequence C: 30 g Fat Breakfast
COMPLETED
|
18
|
|
Sequence C: 30 g Fat Breakfast
NOT COMPLETED
|
0
|
|
Sequence D: 45 g Fat Breakfast
STARTED
|
18
|
|
Sequence D: 45 g Fat Breakfast
COMPLETED
|
18
|
|
Sequence D: 45 g Fat Breakfast
NOT COMPLETED
|
0
|
|
Sequence E: FDA High Fat Breakfast
STARTED
|
18
|
|
Sequence E: FDA High Fat Breakfast
COMPLETED
|
18
|
|
Sequence E: FDA High Fat Breakfast
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate
Baseline characteristics by cohort
| Measure |
Oral Testosterone Undecanoate
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 11.12 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=93 Participants
|
|
Serum testosterone at screening (ng/dL)
|
109.7 ng/dL
STANDARD_DEVIATION 85.98 • n=93 Participants
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12 hours post-dosePeak Concentration after morning dose (Cmax) for oral testosterone undecanoate taken after a fasting breakfast of varying fat content.
Outcome measures
| Measure |
Breakfast A - Fasting
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to Fasting at breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
Breakfast B - 15 g Fat
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 15 g fat breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
Breakfast C - 30 g Fat
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 30 g fat breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
Breakfast D - 45 g Fat
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 45 g fat breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
Breakfast E - High Fat
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to high fat breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
|---|---|---|---|---|---|
|
Cmax-am for Oral TU Across Breakfast With Varying Fat Content
|
250.7 ng/dL
Geometric Coefficient of Variation 48.6
|
334.7 ng/dL
Geometric Coefficient of Variation 57.7
|
529.7 ng/dL
Geometric Coefficient of Variation 33.9
|
506.0 ng/dL
Geometric Coefficient of Variation 37.8
|
463.4 ng/dL
Geometric Coefficient of Variation 62.7
|
PRIMARY outcome
Timeframe: 12 hoursThe time of peak concentration (Tmax-am) will be assessed within each relevant dosing interval.
Outcome measures
| Measure |
Breakfast A - Fasting
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to Fasting at breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
Breakfast B - 15 g Fat
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 15 g fat breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
Breakfast C - 30 g Fat
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 30 g fat breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
Breakfast D - 45 g Fat
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 45 g fat breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
Breakfast E - High Fat
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to high fat breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
|---|---|---|---|---|---|
|
Time of Peak Concentration (Tmax-am)
|
4.000 hours
Interval 0.0 to 4.17
|
2.000 hours
Interval 0.0 to 11.92
|
2.000 hours
Interval 1.83 to 6.0
|
2.000 hours
Interval 1.92 to 11.92
|
2.000 hours
Interval 0.0 to 6.0
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12 hours post-doseThe 12 hours following morning dose area under the curve (AUC) will assessed for each sequence of breakfasts with varying fat content.
Outcome measures
| Measure |
Breakfast A - Fasting
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to Fasting at breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
Breakfast B - 15 g Fat
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 15 g fat breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
Breakfast C - 30 g Fat
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 30 g fat breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
Breakfast D - 45 g Fat
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 45 g fat breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
Breakfast E - High Fat
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to high fat breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
|---|---|---|---|---|---|
|
Area Under the Curve (AUC-am)
|
1905 ng*hr/dL
Geometric Coefficient of Variation 45.2
|
2428 ng*hr/dL
Geometric Coefficient of Variation 51.3
|
3279 ng*hr/dL
Geometric Coefficient of Variation 33.6
|
3395 ng*hr/dL
Geometric Coefficient of Variation 34.7
|
3187 ng*hr/dL
Geometric Coefficient of Variation 52.8
|
PRIMARY outcome
Timeframe: 12 hoursThe time weighted average of total testosterone concentration will be assessed for each dosing interval.
Outcome measures
| Measure |
Breakfast A - Fasting
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to Fasting at breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
Breakfast B - 15 g Fat
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 15 g fat breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
Breakfast C - 30 g Fat
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 30 g fat breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
Breakfast D - 45 g Fat
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 45 g fat breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
Breakfast E - High Fat
n=18 Participants
Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to high fat breakfast and immediately prior to dinner.
Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
|
|---|---|---|---|---|---|
|
Time Weighted Average Total Testosterone Concentration (Cavg-am)
|
160.0 ng/dL
Geometric Coefficient of Variation 45.4
|
203.7 ng/dL
Geometric Coefficient of Variation 51.3
|
275.1 ng/dL
Geometric Coefficient of Variation 33.6
|
285.1 ng/dL
Geometric Coefficient of Variation 34.7
|
267.3 ng/dL
Geometric Coefficient of Variation 52.6
|
Adverse Events
Oral Testosterone Undecanoate 237 mg BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oral Testosterone Undecanoate 237 mg BID
n=18 participants at risk
Subjects will self-administer 237 mg oral TU BID for a 14 day Run-in Phase, followed by 5 consecutive days of twice daily dosing in a phase 1 clinic for serial PK sampling.
|
|---|---|
|
Blood and lymphatic system disorders
iron deficiancy anemia
|
5.6%
1/18 • Number of events 1 • Three months
|
|
Gastrointestinal disorders
abdominal pain upper
|
5.6%
1/18 • Number of events 1 • Three months
|
|
Gastrointestinal disorders
nausea
|
5.6%
1/18 • Number of events 1 • Three months
|
|
General disorders
chest pain
|
5.6%
1/18 • Number of events 1 • Three months
|
|
General disorders
pyrexia
|
5.6%
1/18 • Number of events 1 • Three months
|
|
Infections and infestations
Gastroenteritis
|
5.6%
1/18 • Number of events 1 • Three months
|
|
Infections and infestations
upper respiratory tract infection
|
5.6%
1/18 • Number of events 1 • Three months
|
|
Investigations
prostatic specific antigen increased
|
5.6%
1/18 • Number of events 1 • Three months
|
|
Investigations
white blood cell count increased
|
5.6%
1/18 • Number of events 1 • Three months
|
|
Nervous system disorders
headache
|
5.6%
1/18 • Number of events 1 • Three months
|
|
Renal and urinary disorders
dysuria
|
5.6%
1/18 • Number of events 1 • Three months
|
|
Renal and urinary disorders
pollakiuria
|
5.6%
1/18 • Number of events 1 • Three months
|
|
Reproductive system and breast disorders
prostatitis
|
5.6%
1/18 • Number of events 1 • Three months
|
|
Reproductive system and breast disorders
prostatomegaly
|
5.6%
1/18 • Number of events 1 • Three months
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
5.6%
1/18 • Number of events 1 • Three months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60