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Rifampin Drug-Drug Interaction Study With Lurasidone HCl

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01082276
Recruitment Status : Completed
First Posted : March 8, 2010
Last Update Posted : September 8, 2011
Information provided by (Responsible Party):

Brief Summary:
The effect of rifampin on the pharmacokinetics of lurasidone

Condition or disease Intervention/treatment Phase
Male, Healthy Normal Subjects Drug: Lurasidone HCl Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : August 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01082276

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United States, Maryland
PAREXEL Clinical Pharmacology Research Unit
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
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Principal Investigator: Ronald Goldwater, MD PAREXEL Clinical Pharmacology Research Unit at Baltimore, MD
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Responsible Party: Sunovion Identifier: NCT01082276    
Other Study ID Numbers: D1050270
First Posted: March 8, 2010    Key Record Dates
Last Update Posted: September 8, 2011
Last Verified: September 2011
Keywords provided by Sunovion:
Rifampin DDI with Lurasidone HCl
Additional relevant MeSH terms:
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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