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CompletedNCT02056392Updated Nov 9, 2015Results posted

To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers

A Phase 1 interventional study of Selumetinib and Moxifloxacin in Solid Tumours, sponsored by AstraZeneca. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-09.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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

Read the 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

02

Conditions studied

  • Solid Tumours

Keywords

  • Phase I, healthy, pharmacokinetics
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Selumetinib 75mg

    Volunteers will receive selumetinib 75mg administered by mouth, as a capsule

    Drug: Selumetinib

  • Active comparator
    Moxifloxacin 400 mg

    Volunteers will receive moxifloxacin 400mg administered by mouth, as a capsule

    Drug: Moxifloxacin

  • Placebo comparator
    Selumetinib 75mg placebo

    Volunteers will receive selumetinib 75mg placebo, administered by mouth, as a capsule.

    Drug: selumetinib placebo

Interventions

  • DrugSelumetinib

    Volunteers will receive 75 mg selumetinib oral dose (Treatment A)

    Also known as: AZD6244

  • DrugMoxifloxacin

    Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B)

    Also known as: Avelox®

  • Drugselumetinib placebo

    Volunteers will receive selumetinib placebo oral dose (Treatment C)

    Also known as: AZD6244 placebo

06

What researchers measure

Primary outcomes

  1. Change From Baseline in QTcF

    Change from baseline in QTcF at 30 minutes (msec)

    Time frame: 30 min

  2. Change From Baseline in QTcF

    Change from baseline in QTcF at 1 hour (msec)

    Time frame: 1 hour

  3. Change From Baseline in QTcF

    Change from baseline in QTcF at 1 hour 30 min (msec)

    Time frame: 1 hour 30 min

  4. Change From Baseline in QTcF

    Change from baseline in QTcF at 2 hours (msec)

    Time frame: 2 hours

  5. Change From Baseline in QTcF

    Change from baseline in QTcF at 3 hours (msec)

    Time frame: 3 hours

  6. Change From Baseline in QTcF

    Change from baseline in QTcF at 4 hours (msec)

    Time frame: 4 hours

  7. Change From Baseline in QTcF

    Change from baseline in QTcF at 6 hours (msec)

    Time frame: 6 hours

  8. Change From Baseline in QTcF

    Change from baseline in QTcF at 8 hours (msec)

    Time frame: 8 hours

  9. Change From Baseline in QTcF

    Change from baseline in QTcF at 12 hours (msec)

    Time frame: 12 hours

  10. Change From Baseline in QTcF

    Change from baseline in QTcF at 24 hours (msec)

    Time frame: 24 hours

07

Results

Posted Nov 9, 2015

Participant flow

Participant flow — Overall Study
MilestoneSelumetinib/Moxifloxacin/Selumetinib PlaceboMoxifloxacin/Selumetinib/Selumetinib PlaceboMoxifloxacin/Selumetinib Placebo/SelumetinibSelumetinib Placebo/Moxifloxacin/SelumetinibSelumetinib Placebo/Selumetinib/MoxifloxacinSelumetinib/Selumetinib Placebo/Moxifloxacin
Started1099989
Completed886979
Not completed213010
Withdrew: Lost to follow-up012000
Withdrew: Protocol violation101000
Withdrew: Withdrawal by subject100010

Outcome measures

PrimaryChange From Baseline in QTcF

Change from baseline in QTcF at 30 minutes (msec)

Time frame:
30 min
Reported as:
Least squares mean · msec
Change From Baseline in QTcF
msecMoxifloxacinPlaceboSelumetinib
Change From Baseline in QTcF2.0 (0.5 to 3.5)-4.1 (-5.6 to -2.5)-4.2 (-5.7 to -2.7)
Statistical analysis
  • Placebo vs Selumetinib · Mixed Models Analysis · Mean difference (final values): -0.2 · 90% CI -1.8 to 1.5
  • Moxifloxacin vs Placebo · Mixed Models Analysis · Mean difference (final values): 6.1 · 90% CI 4.4 to 7.7
PrimaryChange From Baseline in QTcF

Change from baseline in QTcF at 1 hour (msec)

Time frame:
1 hour
Reported as:
Least squares mean · msec
Change From Baseline in QTcF
msecMoxifloxacinPlaceboSelumetinib
Change From Baseline in QTcF7.9 (6.4 to 9.4)-1.4 (-2.9 to 0.2)-1.7 (-3.2 to -0.2)
Statistical analysis
  • Placebo vs Selumetinib · Mixed Models Analysis · Mean difference (final values): -0.4 · 90% CI -2.0 to 1.3
  • Moxifloxacin vs Placebo · Mixed Models Analysis · Mean difference (final values): 9.2 · 90% CI 7.6 to 10.8
PrimaryChange From Baseline in QTcF

Change from baseline in QTcF at 1 hour 30 min (msec)

Time frame:
1 hour 30 min
Reported as:
Least squares mean · msec
Change From Baseline in QTcF
msecMoxifloxacinPlaceboSelumetinib
Change From Baseline in QTcF8.1 (6.6 to 9.6)-1.8 (-3.3 to -0.2)-0.9 (-2.4 to 0.6)
Statistical analysis
  • Placebo vs Selumetinib · Mixed Models Analysis · Mean difference (final values): 0.9 · 90% CI -0.7 to 2.5
  • Moxifloxacin vs Placebo · Mixed Models Analysis · Mean difference (final values): 9.9 · 90% CI 8.3 to 11.5
PrimaryChange From Baseline in QTcF

Change from baseline in QTcF at 2 hours (msec)

Time frame:
2 hours
Reported as:
Least squares mean · msec
Change From Baseline in QTcF
msecMoxifloxacinPlaceboSelumetinib
Change From Baseline in QTcF7.9 (6.4 to 9.4)-2.3 (-3.8 to -0.7)-1.9 (-3.4 to -0.4)
Statistical analysis
  • Placebo vs Selumetinib · Mixed Models Analysis · Mean difference (final values): 0.4 · 90% CI -1.2 to 2.0
  • Moxifloxacin · Mixed Models Analysis · Mean difference (final values): 10.1 · 90% CI 8.5 to 11.8
PrimaryChange From Baseline in QTcF

Change from baseline in QTcF at 3 hours (msec)

Time frame:
3 hours
Reported as:
Least squares mean · msec
Change From Baseline in QTcF
msecMoxifloxacinPlaceboSelumetinib
Change From Baseline in QTcF8.8 (7.3 to 10.3)-3.2 (-4.7 to -1.6)-3.3 (-4.8 to -1.8)
Statistical analysis
  • Placebo vs Selumetinib · Mixed Models Analysis · Mean difference (final values): -0.2 · 90% CI -1.8 to 1.5
  • Moxifloxacin vs Placebo · Mixed Models Analysis · Mean difference (final values): 11.9 · 90% CI 10.3 to 13.6
PrimaryChange From Baseline in QTcF

Change from baseline in QTcF at 4 hours (msec)

Time frame:
4 hours
Reported as:
Least squares mean · msec
Change From Baseline in QTcF
msecMoxifloxacinPlaceboSelumetinib
Change From Baseline in QTcF8.6 (7.1 to 10.1)-2.2 (-3.7 to -0.7)-3.7 (-5.2 to -2.2)
Statistical analysis
  • Placebo vs Selumetinib · Mixed Models Analysis · Mean difference (final values): -1.5 · 90% CI -3.1 to 0.2
  • Moxifloxacin vs Placebo · Mixed Models Analysis · Mean difference (final values): 10.8 · 90% CI 9.2 to 12.5
PrimaryChange From Baseline in QTcF

Change from baseline in QTcF at 6 hours (msec)

Time frame:
6 hours
Reported as:
Least squares mean · msec
Change From Baseline in QTcF
msecMoxifloxacinPlaceboSelumetinib
Change From Baseline in QTcF4.7 (3.2 to 6.2)-4.1 (-5.6 to -2.6)-5.9 (-7.4 to -4.4)
Statistical analysis
  • Placebo vs Selumetinib · Mixed Models Analysis · Mean difference (final values): -1.8 · 90% CI -3.4 to -0.1
  • Moxifloxacin vs Placebo · Mixed Models Analysis · Mean difference (final values): 8.8 · 90% CI 7.1 to 10.4
PrimaryChange From Baseline in QTcF

Change from baseline in QTcF at 8 hours (msec)

Time frame:
8 hours
Reported as:
Least squares mean · msec
Change From Baseline in QTcF
msecMoxifloxacinPlaceboSelumetinib
Change From Baseline in QTcF3.6 (2.1 to 5.1)-5.3 (-6.8 to -3.7)-6.5 (-8.0 to -5.0)
Statistical analysis
  • Placebo vs Selumetinib · Mixed Models Analysis · Mean difference (final values): -1.3 · 90% CI -2.9 to 0.4
  • Moxifloxacin vs Placebo · Mixed Models Analysis · Mean difference (final values): 8.9 · 90% CI 7.2 to 10.5
PrimaryChange From Baseline in QTcF

Change from baseline in QTcF at 12 hours (msec)

Time frame:
12 hours
Reported as:
Least squares mean · msec
Change From Baseline in QTcF
msecMoxifloxacinPlaceboSelumetinib
Change From Baseline in QTcF4.2 (2.7 to 5.7)-3.4 (-5.0 to -1.9)-8.2 (-9.7 to -6.7)
Statistical analysis
  • Placebo vs Selumetinib · Mixed Models Analysis · Mean difference (final values): -4.7 · 90% CI -6.4 to -3.1
  • Moxifloxacin vs Placebo · Mixed Models Analysis · Mean difference (final values): 7.6 · 90% CI 6.0 to 9.3
PrimaryChange From Baseline in QTcF

Change from baseline in QTcF at 24 hours (msec)

Time frame:
24 hours
Reported as:
Least squares mean · msec
Change From Baseline in QTcF
msecMoxifloxacinPlaceboSelumetinib
Change From Baseline in QTcF2.4 (0.9 to 3.9)-1.6 (-3.1 to -0.1)-4.1 (-5.6 to -2.6)
Statistical analysis
  • Placebo vs Selumetinib · Mixed Models Analysis · Mean difference (final values): -2.5 · 90% CI -4.1 to -0.9
  • Moxifloxacin vs Placebo · Mixed Models Analysis · Mean difference (final values): 4.0 · 90% CI 2.4 to 5.7

Adverse events

Collected over AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Selumetinib—0/51 (0%)5/51 (9.8%)
Moxifloxacin—0/51 (0%)5/51 (9.8%)
Placebo—1/50 (2%)4/50 (8%)
Most frequent serious events
Most frequent serious events
EventSelumetinibMoxifloxacinPlacebo
HemorrhoidsGastrointestinal disorders0/510/511/50
Most frequent other events
Showing 10 of 12
Most frequent other events
EventSelumetinibMoxifloxacinPlacebo
HeadacheNervous system disorders3/511/510/50
HypersensitivityImmune system disorders0/510/511/50
ArthralgiaMusculoskeletal and connective tissue disorders0/510/511/50
Musculoskeletal painMusculoskeletal and connective tissue disorders0/510/511/50
Skin irritationSkin and subcutaneous tissue disorders0/510/511/50
Disturbance in attentionNervous system disorders0/511/510/50
Abdominal painGastrointestinal disorders0/511/510/50
DyspepsiaGastrointestinal disorders0/511/510/50
Rectal hemorrhageGastrointestinal disorders0/511/510/50
Pain in extremityMusculoskeletal and connective tissue disorders0/511/510/50

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Selumetinib/Moxifloxacin/Selumetinib PlaceboMoxifloxacin/Selumetinib/Selumetinib PlaceboMoxifloxacin/Selumetinib Placebo/SelumetinibSelumetinib Placebo/Moxifloxacin/SelumetinibSelumetinib Placebo/Selumetinib/MoxifloxacinSelumetinib/Selumetinib Placebo/MoxifloxacinTotal
Mean26 ± 725 ± 525 ± 431 ± 828 ± 830 ± 927 ± 7
Sex: Female, Male
Sex: Female, Male(Participants)Selumetinib/Moxifloxacin/Selumetinib PlaceboMoxifloxacin/Selumetinib/Selumetinib PlaceboMoxifloxacin/Selumetinib Placebo/SelumetinibSelumetinib Placebo/Moxifloxacin/SelumetinibSelumetinib Placebo/Selumetinib/MoxifloxacinSelumetinib/Selumetinib Placebo/MoxifloxacinTotal
Female0000000
Male109998954
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Selumetinib/Moxifloxacin/Selumetinib PlaceboMoxifloxacin/Selumetinib/Selumetinib PlaceboMoxifloxacin/Selumetinib Placebo/SelumetinibSelumetinib Placebo/Moxifloxacin/SelumetinibSelumetinib Placebo/Selumetinib/MoxifloxacinSelumetinib/Selumetinib Placebo/MoxifloxacinTotal
White75445429
Black or African American34553525
08

Study locations

1 site
  • Research Site
    Overland Park, Kansas, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02056392
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Feb 6, 2014
Start date
Mar 2014
Primary completion
Aug 2014
Completion
Aug 2014
Results posted
Nov 9, 2015
Last update
Nov 9, 2015

Study contacts

Scott Rasmussen, MD
principal investigator · Quintiles 6700 W 115th Street, Kansas, US

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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