Rifampin Drug-Drug Interaction Study With Lurasidone HCl

The effect of rifampin on the pharmacokinetics of lurasidone

Study Overview

• Status: Completed
• Conditions: Male, Healthy Normal Subjects
• Intervention / Treatment: Drug: Lurasidone HCl

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • PAREXEL Clinical Pharmacology Research Unit

Participation Criteria

Eligibility Criteria

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

Description

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).

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).

Collaborators and Investigators

• Sponsor: Sunovion
• Investigators: Principal Investigator: Ronald Goldwater, MD, PAREXEL Clinical Pharmacology Research Unit at Baltimore, MD

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: March 5, 2010
• First Submitted That Met QC Criteria: March 5, 2010
• First Posted (Estimate): March 8, 2010

Study Record Updates

• Last Update Posted (Estimate): September 8, 2011
• Last Update Submitted That Met QC Criteria: September 6, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Rifampin DDI with Lurasidone HCl
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Lurasidone Hydrochloride
• Other Study ID Numbers: D1050270