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

NCT01124760 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2010-08-03

No results posted yet for this study

Summary

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

Conditions

  • Pharmacokinetics

Interventions

DRUG

AZD9742

Sterile solution, 620 mg (20 mg/mL) in 50 mL vial with a fill volume of 31 mL; On Day 7, a single 150 mg IV dose, coadministered after the morning dose of ketoconazole

DRUG

Diltiazem

Orally, daily beginning on Day 4 for 14 consecutive days

DRUG

ketoconazole

200 mg, orally, every 12 hours starting on Day 4 for 10 consecutive days in which on Day 13 only the morning dose will be administered

Sponsors & Collaborators

Principal Investigators

  • Ralph Schutz, MD · Quintiles, Inc.

  • Colleen Jensen · AstraZeneca

  • Brendan Smyth · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
23 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01124760 on ClinicalTrials.gov