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Open Label Study, Assessing the Effect of Diltiazem or Ketoconazole on the Pharmacokinetics of AZD9742 in Healthy Volunteers

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Pharmacokinetics

Treatments

Drug: ketoconazole
Drug: Diltiazem
Drug: AZD9742

Study type

Interventional

Funder types

Industry

Identifiers

NCT01124760
D2690C00008

Details and patient eligibility

About

The aim of this study is to examine the effect of coadministration of CYP3A4 inhibitors on the pharmacokinetics of AZD9742.

Enrollment

28 patients

Sex

All

Ages

23 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • non-childbearing potential, with suitable veins for cannulation or repeated venipuncture
  • Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at screening.
  • Male volunteers should be willing to use barrier contraception, ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.

Exclusion criteria

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
  • History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
  • Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

28 participants in 1 patient group

1
Experimental group
Description:
AZD9742
Treatment:
Drug: AZD9742
Drug: Diltiazem
Drug: ketoconazole

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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