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AZD1981 Midazolam CYP4503A Induction Study

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Healthy Male Volunteer

Treatments

Drug: Midazolam
Drug: AZD1981

Study type

Interventional

Funder types

Industry

Identifiers

NCT00859352
D9831C00008
EudraCT No. 2008-008224-32

Details and patient eligibility

About

The primary objective of the study is to investigate if the exposure of midazolam is clinically significantly changed by 14 days of exposure to AZD1981 through possible enzyme induction of CYP3A.

Enrollment

28 estimated patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Provision of informed consent prior to any study specific procedures
  • Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
  • Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to Visit 1 (pre-entry)

Exclusion criteria

  • Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
  • Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his participation in the study

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

28 participants in 2 patient groups

1
Experimental group
Description:
AZD1981 100mg and Midazolam
Treatment:
Drug: AZD1981
Drug: Midazolam
2
Experimental group
Description:
AZD1981 500mg and Midazolam
Treatment:
Drug: Midazolam

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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