Rifampin Drug-Drug Interaction Study With Lurasidone HCl

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-08-31

Brief Summary

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The effect of rifampin on the pharmacokinetics of lurasidone

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Detailed Description

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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.

Conditions

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Male, Healthy Normal Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Rifampin/Lurasidone

Healthy Normal Subject

Group Type OTHER

Lurasidone HCl

Intervention Type DRUG

40mg, Single-dose of lurasidone 40 mg (one 40 mg tablet) on Day 1. Daily dosing of rifampin 600 mg (two 300 mg capsules) on Days 1-8. On Day 8, subjects will also receive a single-dose of lurasidone 40 mg (one 40 mg tablet).

Interventions

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Lurasidone HCl

40mg, Single-dose of lurasidone 40 mg (one 40 mg tablet) on Day 1. Daily dosing of rifampin 600 mg (two 300 mg capsules) on Days 1-8. On Day 8, subjects will also receive a single-dose of lurasidone 40 mg (one 40 mg tablet).

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes