Oral Mucosal Absorption of ICI176,334-1

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ICI176,334-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01415791

D6874L00026

Details and patient eligibility

About

The purpose of this study is to investigate the presence or absence of oral mucosal absorption of ICI176,334-1

Full description

Oral mucosal absorption of ICI176,334-1 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Active 1

Experimental group

Description:

8 subjects will receive ICI176,334-1

Treatment:

Drug: ICI176,334-1