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A Study to Assess How Itraconazole Affects the Uptake and Elimination of Capivasertib in the Body

NCT04712396 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-04-09

No results posted yet for this study

Summary

This study will be an open-label, fixed sequence study in healthy subjects (vasectomized males and females of non-childbearing potential), performed at a single study centre.

Conditions

  • Healthy Volunteers (Intended Indication: Metastatic Patients With Triple Negative or HR+ Breast Cancer, or Hormone Sensitive Prostate Cancer)

Interventions

DRUG

Capivasertib

Subects will be administered single doses of capiversatib on Day 1 and Day 6.

DRUG

Itraconazole

Subjects will be administered itraconazole twice daily on Day 3, followed by once daily doses in the morning for 4 days.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Rainard Fuhr, Dr. · Parexel

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
58 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2021-03-25
Completion
2021-03-25
FDA Drug
Yes

Countries

  • Germany

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 NCT04712396 on ClinicalTrials.gov