MedTrace Logo

Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 201335 NA in Healthy Male Subjects

NCT02182362 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2014-07-18

No results posted yet for this study

Summary

The main objective was to investigate the safety, tolerability and the pharmacokinetics (PK) of BI 201335 NA in healthy male subjects without Gilbert's syndrome or polymorphism (GS) following oral administration of a single dose (Day 1) and repeated doses (Days 4-24) of 20 mg, 48 mg, 120 mg, and 240 mg. Additionally, the safety, tolerability, and the PK of the highest tolerated dose of BI 201335 NA (determined during the multiple-rising-dose phase) were assessed in healthy male subjects with GS over a 28-day continuous drug administration period.

Conditions

  • Healthy

Interventions

DRUG

BI 201335 NA

DRUG

Placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-02-29

More Related Trials

Entities

Drugs
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 NCT02182362 on ClinicalTrials.gov