Trial Outcomes & Findings for A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal (NCT NCT01959685)
NCT ID: NCT01959685
Last Updated: 2014-08-11
Results Overview
Cmax of a single dose 125 mg of Androxal
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
24 hrs
Results posted on
2014-08-11
Participant Flow
Participant milestones
| Measure |
Up to 250 mg Androxal
Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal
Baseline characteristics by cohort
| Measure |
Up to 250 mg Androxal
n=9 Participants
Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hrsPopulation: Safety population
Cmax of a single dose 125 mg of Androxal
Outcome measures
| Measure |
Up to 250 mg Androxal
n=9 Participants
Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
|
|---|---|
|
Pharmacokinetics
|
11.0 ng/dL
Standard Deviation 3.1
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Safety population
Outcome measures
| Measure |
Up to 250 mg Androxal
n=9 Participants
Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
|
|---|---|
|
Cmax of a Single Dose of 250 mg Androxal
|
24.9 ng/dL
Standard Deviation 10.4
|
Adverse Events
Up to 250 mg Androxal
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Up to 250 mg Androxal
n=9 participants at risk
Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
|
|---|---|
|
General disorders
Dermatitis contact
|
11.1%
1/9 • Up to 24 hours after last dose of study drug
As all subjects received all treatments (placebo, 125 mg Androxal, and 250 mg Androxal, (adverse events could not be separated by treatment.
|
|
Immune system disorders
Influenza like symptoms
|
11.1%
1/9 • Up to 24 hours after last dose of study drug
As all subjects received all treatments (placebo, 125 mg Androxal, and 250 mg Androxal, (adverse events could not be separated by treatment.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Up to 24 hours after last dose of study drug
As all subjects received all treatments (placebo, 125 mg Androxal, and 250 mg Androxal, (adverse events could not be separated by treatment.
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Up to 24 hours after last dose of study drug
As all subjects received all treatments (placebo, 125 mg Androxal, and 250 mg Androxal, (adverse events could not be separated by treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to publication, Investigator shall submit to the Sponsor a copy of any proposed publication. Sponsor shall have sixty (60) days to review the proposed publication for possible disclosure of Sponsor's Confidential Information and, upon request of Sponsor, Investigator shall delete any of Sponsor's Confidential Information or withhold submission of such publication to allow Sponsor to protect its intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER