Oral Mucosal Absorption Study of Bicalutamide New Formulation

AstraZeneca

Status and phase

Terminated

Phase 1

Conditions

Healthy

Treatments

Drug: ICI176,334-1

Study type

Interventional

Funder types

Industry

Identifiers

NCT01416883

D6874L00016

Details and patient eligibility

About

The purpose of this study is to investigate the presence or absence of oral mucosal absorption of bicalutamide after ICI176,334.1 is given to Japanese healthy male subjects

Full description

Oral mucosal absorption study of ICI176,334-1 (Bicalutamide new formulation) in Japanese healthy male subjects

Enrollment

8 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Provision of signed and dated, written informed consent prior to any study specific procedures
Japanese healthy male subjects aged 20 to 45 years
Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational product
Have a body mass index (BMI) between 17 and 27 kg/m2
Eligible based on the physical findings, supine BP, pulse rate, ECG and laboratory assessments, as judged by the investigator(s)

Exclusion criteria

Presence of any disease under medical treatment
History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunological, blood, endocrine, neurological or mental disease to interfere with absorption, distribution, metabolism or excretion of drugs judged by investigator(s)
Presence of any infectious disease, such as bacteria, virus and fungus Presence of allergic disorder, such as asthma, pollen disease or atopic dermatitis, and judged as necessary any medical treatment
Any large surgical history of gastrointestinal tract such as gastric/intestinal resection or suturation