Rifampin Drug-Drug Interaction Study With Lurasidone HCl

Completed · Phase 1

Conditions studied: Male, Healthy Normal Subjects

In brief

The effect of rifampin on the pharmacokinetics of lurasidone

Key facts

Study ID

NCT01082276

Run by

Sumitomo Pharma America, Inc.

People needed

20

Starts

2008-08-01

Expected to finish

2008-08-01

Last updated by the study team

2011-09-08

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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).
• 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.

You may not qualify if…

• Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
• Use of concomitant medications that prolong the QT/QTc interval from 14 days prior to day - 2 to discharge.
• Use of any inhibitor or inducer of CYP3A4 taken within 30 days prior to study Day -2
• Use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever was longer) prior to Screening.
• Previous exposure to lurasidone (SM-13496).

Where it is running

• PAREXEL Clinical Pharmacology Research Unit — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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