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A Study to Investigate the Absolute Bioavailability, Absorption, Metabolism, Distribution and Excretion of [14C]AZD5363 (Capivasertib)

NCT05419401 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-07-22

No results posted yet for this study

Summary

The Sponsor is developing the test medicine, Capivasertib, for the potential treatment of primary breast and prostate cancer. This two-part healthy volunteer study will try to identify the absolute bioavailability (amount of the test medicine that enters the blood stream), mass balance recovery (how much radioactivity can be recovered from the urine and faeces) and the rates and routes of elimination of the test medicine.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Capivasertib film-coated tablet, 200 mg

400mg dose, oral, fasted

DRUG

[14C]AZD5363 (Capivasertib)

Solution for Infusion 20 µg/mL (NMT 37.0 kBq/5 mL) - 100 µg; 5 mL, Intravenous Oral Solution, 400 mg (NMT 4.8 MBq) - 400mg; 100mL, oral, fasted

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Sharan Sidhu, MBChB, BAO, MRCS, MFPM · Quotient Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-11
Primary Completion
2022-07-12
Completion
2022-07-12

Countries

  • United Kingdom

Study Locations

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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 NCT05419401 on ClinicalTrials.gov