Rifampin Drug-Drug Interaction Study With Lurasidone HCl

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01082276
First received: March 5, 2010
Last updated: September 6, 2011
Last verified: September 2011
  Purpose

The effect of rifampin on the pharmacokinetics of lurasidone


Condition Intervention Phase
Male, Healthy Normal Subjects
Drug: Lurasidone HCl
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Sunovion:

Enrollment: 20
Study Start Date: August 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Rifampin/Lurasidone
Healthy Normal Subject
Drug: 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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082276

Locations
United States, Maryland
PAREXEL Clinical Pharmacology Research Unit
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Sunovion
Investigators
Principal Investigator: Ronald Goldwater, MD PAREXEL Clinical Pharmacology Research Unit at Baltimore, MD
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01082276     History of Changes
Other Study ID Numbers: D1050270
Study First Received: March 5, 2010
Last Updated: September 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Rifampin DDI with Lurasidone HCl

Additional relevant MeSH terms:
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014