Phase 1
N=54
To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers
Solid Tumours
Bottom Line
View on ClinicalTrials.gov: NCT02056392 ↗Enrolled (actual)
54
Serious AEs
0.7%
Results posted
Nov 2015
Primary outcome: Primary: Change From Baseline in QTcF — 2.0; -4.1; -4.2 msec
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Selumetinib (Drug); Moxifloxacin (Drug); selumetinib placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- AstraZeneca
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in QTcF |
2.4; -1.6; -4.1 | — |
| PRIMARY Change From Baseline in QTcF |
2.4; -1.6; -4.1 | — |
| PRIMARY Change From Baseline in QTcF |
2.4; -1.6; -4.1 | — |
| PRIMARY Change From Baseline in QTcF |
2.4; -1.6; -4.1 | — |
| PRIMARY Change From Baseline in QTcF |
2.4; -1.6; -4.1 | — |
| PRIMARY Change From Baseline in QTcF |
2.4; -1.6; -4.1 | — |
| PRIMARY Change From Baseline in QTcF |
2.4; -1.6; -4.1 | — |
| PRIMARY Change From Baseline in QTcF |
2.4; -1.6; -4.1 | — |
| PRIMARY Change From Baseline in QTcF |
2.4; -1.6; -4.1 | — |
| PRIMARY Change From Baseline in QTcF |
2.4; -1.6; -4.1 | — |
Summary
Study to assess the effect of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc interval in healthy male volunteers.
Eligibility Criteria
Inclusion Criteria: 1. Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg (inclusive). 2. Must have not smoked in the last 30 days prior to screening for this study. 3. Have a calculated creatinine clearance (CrCL) greater than 50 mL/min using the Cockcroft-Gault formula.
Exclusion Criteria: 1. Subjects of Japanese or non-Japanese Asian ethnicity. 2. Subjects where any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian (e.g. China, Taiwan, Korea, Philippines, Thailand, Vietnam, and Malaysia). Asian Indians are acceptable. 3. Past history of central serous retinopathy or retinal vein thrombosis,intraocular pressure greater than 21 mmHg or uncontrolled glaucoma. 4. Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs or ECG at baseline in the opinion of the investigator. 5. History or presence of any clinically significant disease or disorder in the opinion of the investigator.
Data sourced from ClinicalTrials.gov (NCT02056392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.