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

Bacterial Enteritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440633
• Other study ID #: 341-14-001
• Status: Completed
• Phase: Phase 1
• First received: May 1, 2015
• Last updated: March 9, 2016
• Start date: May 2015
• Est. completion date: August 2015

Study information

• Verified date: March 2016
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: UK: Medicines & Healthcare products Regulatory Agency (MHRA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 55 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Enteritis

Intervention

Drug:
• 14C-OPS-2071
Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amounts of radioactivity excreted in urine and faeces		up to144-168h postdose.	No
Primary	Area Under Curve (AUC) of total radioactivity in plasma and whole blood		predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.	No
Primary	AUC of OPS-2071 in plasma		predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.	No
Secondary	Number of Adverse Events		Screening, Day-1,0-168h postdose	Yes