Dose-escalation Study to Assess Selumetinib Safety, Tolerability and PK
- Sponsor
- AstraZeneca
- Study ID
- NCT01960374
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy Volunteers Pharmacokinetic Study
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Accepted
Interventions
- Selumetinib — DRUG1, 2 or 3 x 25 mg selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) capsule administered orally as a single dose on Day 1 of the study (total dose 25 mg, 50 mg and 75 mg respectively) with 240 ml of water at room temperature.
Study Details
The purpose of the study is to assess the safety, tolerability and PK of selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in healthy male Japanese and non-Japanese Asian volunteers following administration of a single dose. Standard safety assessments including ECGs, vital signs, blood/urine safety tests, PK samples and monitoring of adverse events and an optional exploratory pharmacogenetics will be performed.
Key Dates
- Start date
- Oct 31, 2013
- Status verified
- May 2014
- Primary completion
- May 31, 2014
- Completion
- May 31, 2014
Study Design
- Enrollment
- 117 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Japanese Arm3 cohorts of 9 subjects. Each cohort will receive oral 25 mg, 50 mg (anticipated) or 75 mg (anticipated) selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate).
- Experimental: Non-Japanese Asian Arm3 cohorts of 9 subjects. Each cohort will receive oral 25 mg, 50 mg (anticipated) or 75 mg (anticipated) selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate).
Primary Outcome Measure
Pharmacokinetics of selumetinib by assessment of maximum plasma selumetinib concentration (Cmax) [ Time Frame: Plasma will be collected at the following time points pre-dose then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36 and 48 hours post dose ]