NCT00935025TerminatedPhase 1
A Single-center, Single-blind, Randomized, Placebo-controlled, Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single and Multiple Ascending Oral Doses of AZD1305 Extended-release Capsules in Healthy Male Japanese and Caucasian Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- AstraZeneca
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight
Study Overview
Brief Summary
This is a phase I, single-blind, randomized, placebo-controlled single and repeated ascending dose study to assess the safety, tolerability and pharmacokinetics with oral doses of AZD1305 extended-release capsules in healthy male Japanese and Caucasian subjects. Three (or four if needed) dose levels will be given to Japanese subjects and one of the doses will also be given to Caucasian subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy Japanese and Caucasian male subjects 20 to 45 years of age inclusive
- •Body weight between 50 and 85 kg, inclusive, with a Body Mass Index (BMI) ≥19 to ≤ 27 kg/m2
Exclusion Criteria
- •Clinically significant illness, surgical procedure or trauma, within two weeks preceding the pre-entry visit until first administration of IP, as judged by the investigator
- •History of clinically significant gastrointestinal, mental, cardiac, renal or hepatic disorder, or other significant disease as judged by the investigator
- •Habitual smoker (daily use) of tobacco or daily use of nicotine-containing products
Arms & Interventions
1, AZD1305
Experimental
Intervention: AZD1305 (Drug)
2, Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight
Time Frame: During the study, from screening period to follow-up, 50 days approximately
Secondary Outcomes
- Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma and urine after single and repeated oral doses(From predose until 48 hrs post last dose)
Investigators
Study Sites (1)
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