Rifampin Drug-Drug Interaction Study With Lurasidone HCl

NCT01082276 | Completed Phase 1 DMC

• 1 other identifier: D1050270
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The effect of rifampin on the pharmacokinetics of lurasidone

Conditions

Male, Healthy Normal Subjects

Keywords

Rifampin DDI with Lurasidone HCl

Study Arms (1)

Rifampin/Lurasidone

OTHER

Healthy Normal Subject

Drug: Lurasidone HCl

Interventions

Lurasidone HCl 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).

Rifampin/Lurasidone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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).

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (1)

PAREXEL Clinical Pharmacology Research Unit

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

Lurasidone Hydrochloride

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ronald Goldwater, MD

  PAREXEL Clinical Pharmacology Research Unit at Baltimore, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 8, 2010
• Study Start: August 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: September 8, 2011

Record last verified: 2011-09

Locations

US (1)