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RDEA3170 Tablet and Capsule Bioavailability Study

NCT02448368 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2018-08-20

Study results available
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Summary

The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules compared with RDEA3170 tablets.

Conditions

  • Healthy

Interventions

DRUG

RDEA3170,10 mg

Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.

DRUG

RDEA3170, 2.5 mg

Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.

DRUG

RDEA3170, 5 mg

Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.

DRUG

RDEA3170, 10 mg

Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.

DRUG

RDEA3170, 2.5 mg

Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.

Sponsors & Collaborators

  • Ardea Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • J Hall, MD · Ardea Biosciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2015-06-26
Completion
2016-01-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02448368 on ClinicalTrials.gov