Study Evaluating the Safety of FXR-450 in Healthy Subjects

Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of FXR-450 Administered Orally to Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00499629

Enrollment

Registered

2007-07-11

Start date

2007-10-31

Completion date

2008-02-29

Last updated

2008-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

healthy subjects

Brief summary

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.

Interventions

DRUGFXR 450

capsule, single oral doses from 10 mg to 450 mg

DRUGplacebo

capsule similar to active drug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Safety, tolerability	4 days

Secondary

Measure	Time frame
pharmacokinetics	4 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026