Study Evaluating the Safety of FXR-450 in Healthy Subjects

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: FXR 450; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00499629

3213A1-1000

Details and patient eligibility

About

The primary purpose of the study is to evaluate the safety of FXR-450 in healthy subjects. This study will also evaluate pharmacokinetics (PK) of FXR-450 in healthy subjects.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive at screening.
• Healthy as determined by the investigator on the basis of screening evaluations.
• Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion criteria

• Any significant medical disease.
• History of cholecystectomy (removal of gallbladder).
• Any clinically important finding in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results.

Trial design

64 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Arm 1: FXR 450

Treatment:

Drug: FXR 450

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo