Rifampin Drug-Drug Interaction Study With Lurasidone HCl

Sumitomo Pharma

Status and phase: Completed; Phase 1

Conditions: Male, Healthy Normal Subjects

Treatments: Drug: Lurasidone HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT01082276

D1050270

Details and patient eligibility

About

The effect of rifampin on the pharmacokinetics of lurasidone

Full description

by performing an open-label, 2-period, sequential study in healthy subjects. All subjects (N=20) will be assigned to the same treatment sequence, 40 mg po dosing.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

20 participants in 1 patient group

Rifampin/Lurasidone

Other group

Description:

Healthy Normal Subject

Treatment:

Drug: Lurasidone HCl