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AZD4635 Relative Bioavailability Study

NCT03710434 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-05-07

No results posted yet for this study

Summary

To investigate the pharmacokinetics and relative bioavailability of AZD4635 solid oral formulation and compare with the nano-suspension reference formulation with the option to assess food effect, pH effect and absolute bioavailability

Conditions

  • Healthy Volunteers

Interventions

DRUG

AZD4635 50 mg nano-suspension (reference)

Subjects will receive a single dose of AZD4635 50 mg nano-suspension (reference) in the fasted state.

DRUG

AZD4635 solid oral formulation - fasted

Subjects will receive a single dose of AZD4635 solid oral formulation, in the fasted state.

DRUG

AZD4635 solid oral formulation - fed

Subjects will receive a single dose of AZD4635 solid oral formulation, in the fed state.

DRUG

Lansoprazole and AZD4635 50 mg solid oral formulation

Subjects will receive lansoprazole 30 mg BID for 5 days followed by a single dose of AZD4635 50 mg solid oral formulation in the fasted state.

DRUG

AZD4635 solid oral formulation variant 1 - fasted

Subjects will receive a single dose of AZD4635 solid oral formulation, variant 1 in the fasted state.

DRUG

AZD4635 solid oral formulation variant 2 - fasted

Subjects will receive a single dose of AZD4635 solid oral formulation, variant 2 in the fasted state.

DRUG

[14C] AZD4635 IV microtracer - fasted

Subjects will receive a single dose of \[14C\] AZD4635 IV microtracer. This intervention will be co-administered with AZD4635 solid oral formulation variant 1.

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Sharan Sidhu, MBChB, BAO, MRCS, MFPM · Quotient Sciences Limited (indemnified by Medical Protection Society)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-04-02
Completion
2019-04-02

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 NCT03710434 on ClinicalTrials.gov