Rifampin Drug-Drug Interaction Study With Lurasidone HCl

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The effect of rifampin on the pharmacokinetics of lurasidone

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sunovion
• Treatments: Lurasidone Hydrochloride; Rifampin

Criteria

Inclusion Criteria:

1. Female subjects must be of nonchildbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year) with follicle stimulating hormone [FSH] > 40 U/L).

2. Subjects with partners of child-bearing potential must agree to use barrier contraception during the study and for 90 days after discharge. Volunteers must agree to not donate sperm during the study and for 90 days after discharge.

Exclusion Criteria:

1. Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.

2. Use of concomitant medications that prolong the QT/QTc interval from 14 days prior to day - 2 to discharge.

3. Use of any inhibitor or inducer of CYP3A4 taken within 30 days prior to study Day -2

4. Use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever was longer) prior to Screening.

5. Previous exposure to lurasidone (SM-13496).