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RI-AME Study OF [ISOTHIAZOLYL-3-14C]-LURASIDONE

Sumitomo Pharma logo

Sumitomo Pharma

Status and phase

Completed
Phase 1

Conditions

Metabolism
Pharmacokinetics

Treatments

Drug: Lurasidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01082146
D1050262

Details and patient eligibility

About

This will be an open-label, non-randomized, absorption, metabolism, and excretion study of Lurasidone administered in a suspension at 40 mg to 6 normal healthy male subjects in a postprandial state

Full description

A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [Isothiazolyl-3-14C]-Lurasidone Following Postprandial Single Oral Dose Administration in Healthy Male Subjects.

Enrollment

6 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. within a BMI range of 18.0 to 28.0 kg/m2 inclusive;
  2. males will either be sterile or agree to use from Check-in until 45 days following Study Completion/Discharge approved methods of contraception
  3. able to comprehend and willing to sign an Informed Consent Form (ICF);
  4. able to void urine on a daily basis and 1 to 2 bowel movements per day.
  5. able to swallow 60 mL of dosing suspension.

Exclusion criteria

  1. history or presence of an abnormal ECG
  2. participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in.
  3. exposure to significant radiation within 12 months prior to Check-in;
  4. participation in any other investigational study drug trial
  5. use of any prescription medications/products within 14 days prior to Check-in
  6. use of any inhibitors or inducers of CYP3A4 taken within 30 days prior to Check-in, including but not limited to drugs listed in Appendix E;
  7. receipt of blood products within 2 months prior to Check-in;

Trial design

6 participants in 1 patient group

Lurasidone
Experimental group
Description:
LURASIDONE 40mg
Treatment:
Drug: Lurasidone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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