CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
AZD9496 (Reference) +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02780713
NCT02780713Phase 1Completed

A Phase I Study to Evaluate the Pharmacokinetic and Safety Profile of AZD9496 Following Single Dose Administration of Different Forms and Formulations in Healthy Subjects

AstraZeneca·interventional·Posted May 23, 2016·Updated Aug 25, 2021

In Brief

A Phase 1 clinical trial evaluating AZD9496 (Reference), AZD9496 Variant A, and 3 other interventions for Breast Cancer. Completed, enrolled 14 participants across 1 site.

Detailed Summary

This is a phase 1 open label single centre study of AZD9496 administered orally in healthy volunteers. The study design involves single administration of different forms, formulations and doses of AZD9496. The study is designed to investigate these different AZD9496 variants. The study will evaluate the pharmacokinetic profiles and the safety and tolerability of the different forms, formulations and doses of AZD9496 This is a fixed sequence study with 5-sequential treatment periods in healthy volunteers. Each volunteer will receive 5 single doses of AZD9496 in different forms, formulations and doses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsParexel

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 23, 2016
Enrollment StartJun 2, 2016
Primary CompletionSep 20, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.1 years ago

Interventions

AZD9496 (Reference)drug

AZD9496 (Reference)

AZD9496 Variant Adrug

AZD9496 Variant A.

AZD9496 Variant Bdrug

AZD9496 Variant B

AZD9496 Variant Cdrug

AZD9496 Variant C

AZD9496 Variant Ddrug

AZD9496 Variant D