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Study to Assess Safety, Tolerability, and Pharmacokinetics of Oral Doses for AC430 in Healthy Subjects

NCT01287858 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2015-11-02

No results posted yet for this study

Summary

AC430 will be administered, orally under fasting conditions (fasting 4 hours before and 2 hours after dosing) with approximately 240 mL of water either once daily or twice daily. It is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AC430.

Conditions

Interventions

DRUG

AC430

Healthy volunteers will either receive AC430 or placebo.

Sponsors & Collaborators

Principal Investigators

  • Guy Gammon, MB BS, MRCP · Interim Chief Medical Officer / Ambit Biosciences Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT01287858 on ClinicalTrials.gov