NCT00859352

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2009

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

April 10, 2009

Status Verified

April 1, 2009

First QC Date

March 10, 2009

Last Update Submit

April 9, 2009

Conditions

Healthy Male Volunteer

Outcome Measures

Primary Outcomes (1)

  • PK samples for both AZD1981 and Midazolam.

    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 (2)

  • Sampling of 4β-hydroxycholesterol

    Taken at baseline and after steady state of AZD1981

  • Safety variables (adverse events and laboratory safety lab)

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

Study Arms (2)

1

EXPERIMENTAL

AZD1981 100mg and Midazolam

Drug: AZD1981Drug: Midazolam

2

EXPERIMENTAL

AZD1981 500mg and Midazolam

Drug: Midazolam

Interventions

AZD1981DRUG

oral tablets during 14 consecutive days.

1
MidazolamDRUG

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.

12

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Uppsala, Sweden

Location

MeSH Terms

Interventions

AZD1981Midazolam

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Eva Pettersson

    AstraZeneca R&D, Lund, Sweden

    STUDY DIRECTOR

  • Aslak Rautio

    Quintiles Hermelinen AB, Luleå, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 10, 2009

First Posted

March 11, 2009

Study Start

March 1, 2009

Study Completion

April 1, 2009

Last Updated

April 10, 2009

Record last verified: 2009-04

Locations

SE(1)