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A Study to Assess the Effects of Itraconazole, Rifampicin, and Omeprazole on Pharmacokinetics of Adavosertib

NCT04959266 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-09-16

No results posted yet for this study

Summary

This is a Phase 1, open-label, non-randomised, 3-arm (A, B, and C), drug-drug interaction study in patients with advanced solid tumours.

Conditions

  • Advanced Solid Tumours

Interventions

DRUG

Adavosertib

Patients will receive a single dose of Adavosertib orally in arm A, B, and C.

DRUG

Itraconazole

Patients will receive Itraconazole orally once daily for 7 days in arm A.

DRUG

Rifampicin

Patients will receive Rifampicin orally once daily for 13 days in arm B.

DRUG

Omeprazole

Patients will receive Omeprazole orally once daily for 5 days in arm C.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-28
Primary Completion
2022-06-01
Completion
2022-06-01
FDA Drug
Yes

Countries

  • United States
  • Spain

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 NCT04959266 on ClinicalTrials.gov