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Rifampin Drug-Drug Interaction Study With Lurasidone HCl

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

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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 identifier: NCT01082276

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

Responsible Party: Sunovion 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:
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers processed this record on October 28, 2016