Study to Assess Drug Concentrations in Plasma of Different Extended-release Formulations of AZD1305

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD1305

Study type: Interventional

Funder types: Industry

Identifiers

NCT00957437

D3190C00016

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics of different extended-release formulations of AZD1305 when given as single and multiple oral doses to healthy male volunteers.

Enrollment: 24 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed, written and dated informed consent prior to any study specific procedures.
• Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.

Exclusion criteria

• History or presence of any clinically significant disease or disorder in the opinion of the investigator.
• Use of nicotine in the last 4 weeks before screening and not more than 7 cigarettes per week (equivalent to 1 nicotine patch or 7 nicotine gums per week) before then. There will be no smoking until follow-up visit.
• Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Part A: 3 way crossover

Experimental group

Description:

AZD1305: ER test formulation 1 (w/wo food) and reference formulation

Treatment:

Drug: AZD1305

Drug: AZD1305

Drug: AZD1305

Part B1: single arm

Experimental group

Description:

AZD1305: ER test formulation 1

Treatment:

Drug: AZD1305

Drug: AZD1305

Drug: AZD1305

Part B2: 3 way crossover

Experimental group

Description:

AZD1305: ER test formulation 2 (w/wo food) and reference formulation

Treatment:

Drug: AZD1305

Drug: AZD1305

Drug: AZD1305