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A Cross-over Study Examining the Bioequivalence of 3 Test Formulations to a Reference Formulation of Alectinib (RO5424802) in Healthy Volunteers

NCT02074553 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2023-12-11

Study results available
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Summary

This 2-part, single center, open-label, randomized, single-dose, 4-sequence, 4-period cross-over study will compare the bioequivalence of three test RO5424802 capsule formulations with the reference capsule formulation in healthy adult volunteers. All participants in both fasted (Part 1) and fed (Part 2) conditions of the study will receive each of 4 treatments (Ro542-4802/F03 \[RO5424802 with 50 percentage (%) sodium lauryl sulfate (SLS) (reference)\], Ro542-4802/F07 \[RO5424802 with 25% SLS (test)\], Ro542-4802/F14 \[RO5424802 with 12.5% SLS (test)\] and Ro542-4802/F08 \[RO5424802 with 3% SLS (test)\] in a randomized sequence. Each treatment will be given as a single 600 milligrams (mg) oral administration in an upright position on Day 1 after an overnight fast, followed by a 10-day washout period. Total time on study is expected to last up to 75 days, for each enrolled participant.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Ro542-4802/F03 (Reference)

Participants will receive Ro542-4802/F03 (containing 50% SLS) 600 mg capsules orally on Day 1.

DRUG

Ro542-4802/F07 (Test)

Participants will receive Ro542-4802/F07 (containing 25% SLS) 600 mg capsules orally on Day 1.

DRUG

Ro542-4802/F08 (Test)

Participants will receive Ro542-4802/F08 (containing 3% SLS) 600 mg capsules orally on Day 1.

DRUG

Ro542-4802/F14 (Test)

Participants will receive Ro542-4802/F14 (containing 12.5% SLS) 600 mg capsules orally on Day 1.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02074553 on ClinicalTrials.gov