Trial Outcomes & Findings for A Study to Assess the Absolute Bioavailability of Oral Selumetinib in Healthy Male Volunteers. (NCT NCT02238782)
NCT ID: NCT02238782
Last Updated: 2016-04-05
Results Overview
To calculate absolute bioavailability we used the formula: Area Under the Curve (oral dose)/Area Under the Curve (intravenous dose)\*100
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
0 to 72 hours post-dose
Results posted on
2016-04-05
Participant Flow
21 subjects were enrolled, 12 of these subjects went on to receive treatment
Participant milestones
| Measure |
Selumetinib
Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
Subjects Treated
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Absolute Bioavailability of Oral Selumetinib in Healthy Male Volunteers.
Baseline characteristics by cohort
| Measure |
Selumetinib
n=12 Participants
Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
|
|---|---|
|
Age, Continuous
|
42 Years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 72 hours post-doseTo calculate absolute bioavailability we used the formula: Area Under the Curve (oral dose)/Area Under the Curve (intravenous dose)\*100
Outcome measures
| Measure |
Selumetinib
n=12 Participants
Selumetinib 75 mg oral followed by IV carbon 14 selumetinib (80 micrograms) administered 1 hour 15 minutes after the oral dose.
|
|---|---|
|
Absolute Bioavailability
|
62.1 % of bioavailability
Interval 60.1 to 64.1
|
Adverse Events
Selumetinib
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Selumetinib
n=12 participants at risk
Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
|
|---|---|
|
Nervous system disorders
Head Ache
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acne
|
8.3%
1/12 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place