AZD1981 Midazolam CYP4503A Induction Study - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00859352

Purpose

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.

Condition	Intervention	Phase
Healthy Male Volunteer	Drug: AZD1981 Drug: Midazolam	Phase I

Drug Information available for: Midazolam Midazolam maleate Midazolam hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Official Title:	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.

Further study details as provided by AstraZeneca:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sampling of 4β-hydroxycholesterol [ Time Frame: Taken at baseline and after steady state of AZD1981 ] [ Designated as safety issue: No ]
Safety variables (adverse events and laboratory safety lab) [ Time Frame: Adverse events taken during study and safety lab at a few time points ] [ Designated as safety issue: No ]

Estimated Enrollment:	28
Study Start Date:	March 2009
Study Completion Date:	April 2009

Arms	Assigned Interventions
1: Experimental AZD1981 100mg and Midazolam	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.
2: Experimental AZD1981 500mg and Midazolam	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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859352

Locations

Sweden
Research Site
UPPSALA, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Eva Pettersson	AstraZeneca R&D, Lund, Sweden
Principal Investigator:	Aslak Rautio	Quintiles Hermelinen AB, Luleå, Sweden

More Information

No publications provided

Responsible Party:	AstraZeneca R&D Lund, Sweden ( Christer Hultquist, Medical Science Director )
Study ID Numbers:	D9831C00008, EudraCT No. 2008-008224-32
Study First Received:	March 10, 2009
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00859352 History of Changes
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Anesthetics, General
Hypnotics and Sedatives
Psychotropic Drugs

Adjuvants, Immunologic
Central Nervous System Depressants
Anesthetics
Anti-Anxiety Agents
Healthy
Midazolam

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Central Nervous System Depressants

Midazolam
Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009