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CompletedNCT00859352Updated Apr 10, 2009

AZD1981 Midazolam CYP4503A Induction Study

A Phase 1 interventional study of AZD1981 and Midazolam in Healthy Male Volunteer, sponsored by AstraZeneca. Completed at 1 site in Sweden. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-04-10.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Healthy Male Volunteer
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    1

    AZD1981 100mg and Midazolam

    Drug: AZD1981 · Drug: Midazolam

  • Experimental
    2

    AZD1981 500mg and Midazolam

    Drug: Midazolam

Interventions

  • DrugAZD1981

    oral tablets during 14 consecutive days.

  • DrugMidazolam

    Each subject will receive two single doses of 7.5 mg midazolam given as oral solution. The Midazolam dose will be given on Day 1 and on day 16.

06

What researchers measure

Primary outcomes

  1. PK samples for both AZD1981 and Midazolam.

    Time frame: Intense PK-sampling during 3 pre-defined study days for PK profiling and some sampling throughout the whole study period for confirmatory purposes

Secondary outcomes

  1. Sampling of 4β-hydroxycholesterol

    Time frame: Taken at baseline and after steady state of AZD1981

  2. Safety variables (adverse events and laboratory safety lab)

    Time frame: Adverse events taken during study and safety lab at a few time points

07

Study locations

1 site
  • Research Site
    Uppsala, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00859352
Lead sponsor
AstraZeneca
First posted
Mar 11, 2009
Start date
Mar 2009
Completion
Apr 2009
Last update
Apr 10, 2009

Study contacts

Eva Pettersson
study director · AstraZeneca R&D, Lund, Sweden
Aslak Rautio
principal investigator · Quintiles Hermelinen AB, Luleå, Sweden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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