Conditions: Solid Tumours
Keywords: Phase I, healthy, pharmacokinetics
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 54
Healthy volunteers: yes

Brief summary:
Study to assess the effect of Selumetinib \[AZD6244; ARRY-142886\] \[Hyd-Sulfate\]), on QTc interval in healthy male volunteers.

Detailed description:
A double-blind (Selumetinib \[AZD6244; ARRY-142886\] \[Hyd-Sulfate\]), Placebo-controlled, Open-Label (Moxifloxacin) Positive-controlled, Randomized, Three-period Crossover Study to Assess the Effects of Single Oral Dose of Selumetinib (75 mg) on QTc Interval Compared to Placebo, using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers

Arms:
arm 1: Volunteers will receive selumetinib 75mg administered by mouth, as a capsule arm 2: Volunteers will receive moxifloxacin 400mg administered by mouth, as a capsule arm 3: Volunteers will receive selumetinib 75mg placebo, administered by mouth, as a capsule.

Interventions: intervention 1: Selumetinib intervention 2: Moxifloxacin intervention 3: selumetinib placebo
Intervention descriptions: intervention 1: Volunteers will receive 75 mg selumetinib oral dose (Treatment A) intervention 2: Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B) intervention 3: Volunteers will receive selumetinib placebo oral dose (Treatment C)

Protocol document: