Rifampin Drug-Drug Interaction Study With Lurasidone HCl | NCT01082276

Studies
Rifampin Drug-Drug Interaction Study With Lurasidone HCl

NCT01082276

Sponsor

Sumitomo Pharma America, Inc.

Status

Completed

Last Update Posted

Sep 8, 2011Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Male, Healthy Normal Subjects

Interventions

Lurasidone HCl

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Mar 5, 2010

First Submission Date that Met QC Criteria

Mar 5, 2010

First Posted Date

Mar 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2011

Last Update Posted Date

Sep 8, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The effect of rifampin on the pharmacokinetics of lurasidone

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rifampin/Lurasidone	Other	Healthy Normal Subject	Drug: Lurasidone HCl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ronald Goldwater, MD	PAREXEL Clinical Pharmacology Research Unit at Baltimore, MD	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PAREXEL Clinical Pharmacology Research Unit		Baltimore	Maryland	21225	United States

Intervention Browse Module

MeSH Terms

ID	Term
D000069056	Lurasidone Hydrochloride

Ancestor Terms

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles

Browse Leaves

Not provided

Browse Branches

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