AZD1981 Midazolam CYP4503A Induction Study

Overview

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.

Full Title of Study: “A Phase I, Open, Randomised, Non-Comparative, Parallel Group Study of a Potential Cytochrome P450 3A Induction After Repeat Twice Daily Oral Dosing With 100 and 500 mg AZD1981 Tablets for 14 Days to Healthy Male Volunteers With Single Oral Doses of Midazolam 7.5 mg.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)

Interventions

  • Drug: AZD1981
    • oral tablets during 14 consecutive days.
  • Drug: Midazolam
    • 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.

Arms, Groups and Cohorts

  • Experimental: 1
    • AZD1981 100mg and Midazolam
  • Experimental: 2
    • AZD1981 500mg and Midazolam

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Sampling of 4β-hydroxycholesterol
    • Time Frame: Taken at baseline and after steady state of AZD1981
  • Safety variables (adverse events and laboratory safety lab)
    • Time Frame: Adverse events taken during study and safety lab at a few time points

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Christer Hultquist, Medical Science Director, AstraZeneca R&D Lund, Sweden
  • Overall Official(s)
    • Eva Pettersson, Study Director, AstraZeneca R&D, Lund, Sweden
    • Aslak Rautio, Principal Investigator, Quintiles Hermelinen AB, Luleå, Sweden

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