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Exploratory Study to Assess the Pharmacokinetics of AZD5985

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: AZD5985
Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00799331
D2300C00001
EudraCt No. 2008-005121-11

Details and patient eligibility

About

The aim of this exploratory study is to assess the pharmacokinetics of increasing oral doses of AZD5985 in healthy male volunteers

Enrollment

32 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.
  • Healthy male subjects aged 18 to 45 years (inclusive).
  • Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
  • Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start.

Exclusion criteria

  • History or presence of any clinically significant disease or disorder in the opinion of the investigator.
  • Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
  • Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

32 participants in 2 patient groups

A
Experimental group
Description:
AZD5985
Treatment:
Drug: AZD5985
B
Experimental group
Description:
placebo
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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