At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 32 enrolled

Drug / intervention

BIIB118 +2 moredrug

Likely dose

BIIB118 3 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02443740

NCT02443740Phase 1Completed

Compare CT.gov

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In Brief

A Phase 1 clinical trial evaluating BIIB118 for Healthy. Completed, enrolled 32 participants across 1 site.

Detailed Summary

This is a First in human (FIH) single ascending dose study to evaluate the safety, tolerability and pharmacokinetics (PKs) of BIIB118 following single oral doses in healthy human subjects

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHealthy

CountriesUnited States

Collaborators--

Timeline

Phase 1CompletedFinished

20162017201820192020202120222023202420252026

First PostedMay 2015

Enrollment StartMay 2015

Primary CompletionOct 2015

TodayJul 2026

First PostedMay 14, 2015

Enrollment StartMay 31, 2015

Primary CompletionOct 31, 2015

TodayJul 2, 2026

Enrollment to primary: 5 monthsPosted 11.1 years ago

Interventions

BIIB118drug

Single ascending doses of BIIB118 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 3 mg, 30 mg, 200 mg, 800 mg and placebo

BIIB118drug

Single ascending doses of BIIB118 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 10 mg, 100 mg, 400 mg, and placebo

BIIB118drug

Single dose (Maximum Tolerated Dose) of BIIB118 as extemporaneously prepared solution/suspension