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A Study to Assess the Bioavailability of Different Formulations of AZD5718 and the Food Effect on the Selected Formulation of AZD5718 in Healthy Volunteers

NCT03420092 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-04-23

No results posted yet for this study

Summary

In this study, the relative bioavailability of different formulations of AZD5718 will be determined in order to compare it with the formulation used in a previous Phase 2a study and confirm appropriate drug exposure. This study consist of 2 parts. In Part 1, 5 different formulations of AZD5718 would be provided to the participant in fasting condition in a randomized order. After evaluation of Part 1 a single formulation would be selected for dosing in fed condition in Part 2. Each participant will be involved in the study for approximately 5 to 6 weeks. Fourteen participants will be randomized to ensure at least 10 evaluable participants at the end of the last treatment period.

Conditions

Interventions

DRUG

Form 1 of AZD5718 tablets

The participants will be dosed with Form 1 of AZD5718 following an overnight fast of at least 10 hours.

DRUG

Form 2 of AZD5718 tablets

The participants will be dosed with Form 2 of AZD5718 following an overnight fast of at least 10 hours.

DRUG

Form 3 of AZD5718 tablets

The participants will be dosed with Form 3 of AZD5718 following an overnight fast of at least 10 hours.

DRUG

Form 4 of AZD5718 tablets

The participants will be dosed with Form 4 of AZD5718 following an overnight fast of at least 10 hours.

DRUG

Form 5 of AZD5718 tablets

The participants will be dosed with Form 5 of AZD5718 following an overnight fast of at least 10 hours.

DRUG

Selected form (Form 2 - 5) of AZD5718 tablets

The participant will be administered with selected form (one of Form 2-5) of AZD5718 tablets 30 minutes after start of the meal.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Pablo Forte Soto, MD · PAREXEL Early Phase Clinical Unit London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-02-05
Primary Completion
2018-04-18
Completion
2018-04-18

Countries

  • United Kingdom

Study Locations

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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 NCT03420092 on ClinicalTrials.gov