A Phase 1,Open -Label Study to Assess the Absorption, Metabolism and Excretion of 14C-OPS-2071 Following a Single Oral Dose to Healthy Male Japanese Subjects

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Otsuka

Status and phase

Completed
Phase 1

Conditions

Bacterial Enteritis

Treatments

Drug: 14C-OPS-2071

Study type

Interventional

Funder types

Industry

Identifiers

NCT02440633
341-14-001

Details and patient eligibility

About

To obtain absorption, metabolism and excretion data for parent drug and any metabolites.

Enrollment

8 patients

Sex

Male

Ages

35 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy males
  • Body mass index (BMI) between 18.5 and 25.0 kg/m2, inclusive
  • Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

Exclusion criteria

  • Subjects who have a significant history of alcoholism or drug/chemical abuse, as determined by the Investigator.
  • Subjects who smoke, or who have used nicotine within 3 months prior to screening..
  • Subjects who have a significant history of drug allergy, as determined by the Investigator.
  • Subjects who have any clinically significant abnormal physical examination finding.
  • Subjects who have any clinically significant medical history, as determined by the Investigator.
  • Subjects who are exposed to radiation as a result of their occupation.
  • Subjects who have had an X ray or CT scan, or who have participated in any trial involving a radiolabelled investigational product or have been exposed to radiolabelled substances within 12 months prior to dose administration.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

14C-OPS-2071
Experimental group
Description:
Suspension containing 50 mg of 14C-OPS-2071
Treatment:
Drug: 14C-OPS-2071

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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