Trial Outcomes & Findings for A Study of Tadalafil in Benign Prostatic Hyperplasia (NCT NCT01183650)
NCT ID: NCT01183650
Last Updated: 2012-05-16
Results Overview
AUC for Day 1 is reported as AUC(tau \[t\], day 1), which is AUC from time zero to 24 hours (t) postdose on Day 1. AUC for Day 10 is reported as AUC(t,steady state \[ss\]), which is AUC during one 24-hour dosing interval at steady-state.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
1 day and 10 days
Results posted on
2012-05-16
Participant Flow
Participant milestones
| Measure |
Japanese Participants
Japanese participants who received 5 mg of tadalafil once daily for 10 days
|
Caucasian Participants
Caucasian participants who received 5 mg of tadalafil once daily for 10 days
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Tadalafil in Benign Prostatic Hyperplasia
Baseline characteristics by cohort
| Measure |
Japanese Participants
n=12 Participants
Japanese participants who received 5 mg of tadalafil once daily for 10 days
|
Caucasian Participants
n=12 Participants
Caucasian participants who received 5 mg of tadalafil once daily for 10 days
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
57.0 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
12 participants
n=5 Participants
|
0 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 day and 10 daysPopulation: All enrolled participants
AUC for Day 1 is reported as AUC(tau \[t\], day 1), which is AUC from time zero to 24 hours (t) postdose on Day 1. AUC for Day 10 is reported as AUC(t,steady state \[ss\]), which is AUC during one 24-hour dosing interval at steady-state.
Outcome measures
| Measure |
Japanese Participants
n=12 Participants
Japanese participants who received 5 mg of tadalafil once daily for 10 days
|
Caucasian Participants
n=12 Participants
Caucasian participants who received 5 mg of tadalafil once daily for 10 days
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC) for Tadalafil and Metabolite IC710
Day 1 Tadalafil
|
1410 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 31
|
1340 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 17
|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC) for Tadalafil and Metabolite IC710
Day 10 Tadalafil
|
2710 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 27
|
3410 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 51
|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC) for Tadalafil and Metabolite IC710
Day 1 Metabolite IC710
|
525 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 27
|
399 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 23
|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC) for Tadalafil and Metabolite IC710
Day 10 Metabolite IC710
|
2270 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 30
|
2290 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 48
|
PRIMARY outcome
Timeframe: 1 day and 10 daysPopulation: All enrolled participants
Outcome measures
| Measure |
Japanese Participants
n=12 Participants
Japanese participants who received 5 mg of tadalafil once daily for 10 days
|
Caucasian Participants
n=12 Participants
Caucasian participants who received 5 mg of tadalafil once daily for 10 days
|
|---|---|---|
|
Pharmacokinetics: Concentration Maximum (Cmax) of Tadalafil and Metabolite IC710
Day 1 Tadalafil
|
102 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 27
|
104 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 19
|
|
Pharmacokinetics: Concentration Maximum (Cmax) of Tadalafil and Metabolite IC710
Day 10 Tadalafil
|
173 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 24
|
215 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 36
|
|
Pharmacokinetics: Concentration Maximum (Cmax) of Tadalafil and Metabolite IC710
Day 1 Metabolite IC710
|
32.1 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
24.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 26
|
|
Pharmacokinetics: Concentration Maximum (Cmax) of Tadalafil and Metabolite IC710
Day 10 Metabolite IC710
|
105 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
102 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 47
|
PRIMARY outcome
Timeframe: 1 day and 10 daysPopulation: All enrolled participants
Outcome measures
| Measure |
Japanese Participants
n=12 Participants
Japanese participants who received 5 mg of tadalafil once daily for 10 days
|
Caucasian Participants
n=12 Participants
Caucasian participants who received 5 mg of tadalafil once daily for 10 days
|
|---|---|---|
|
Pharmacokinetics: Time to Concentration Maximum (Tmax) of Tadalafil and Metabolite IC710
Day 1 Tadalafil
|
4.00 hours
Interval 1.0 to 4.0
|
2.00 hours
Interval 1.0 to 4.0
|
|
Pharmacokinetics: Time to Concentration Maximum (Tmax) of Tadalafil and Metabolite IC710
Day 10 Tadalafil
|
3.00 hours
Interval 2.0 to 4.0
|
2.53 hours
Interval 1.0 to 4.0
|
|
Pharmacokinetics: Time to Concentration Maximum (Tmax) of Tadalafil and Metabolite IC710
Day 1 Metabolite IC710
|
23.83 hours
Interval 23.83 to 23.83
|
24.00 hours
Interval 16.02 to 24.03
|
|
Pharmacokinetics: Time to Concentration Maximum (Tmax) of Tadalafil and Metabolite IC710
Day 10 Metabolite IC710
|
4.00 hours
Interval 0.0 to 24.0
|
8.00 hours
Interval 0.0 to 24.0
|
Adverse Events
Japanese Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caucasian Participants
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Japanese Participants
n=12 participants at risk
Japanese participants who received 5 mg of tadalafil once daily for 10 days
|
Caucasian Participants
n=12 participants at risk
Caucasian participants who received 5 mg of tadalafil once daily for 10 days
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12
|
16.7%
2/12 • Number of events 4
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/12
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Chest pain
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12
|
25.0%
3/12 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12
|
25.0%
3/12 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12
|
16.7%
2/12 • Number of events 2
|
|
Nervous system disorders
Headache
|
0.00%
0/12
|
33.3%
4/12 • Number of events 4
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60