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NCT02780713 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Pharmacokinetics and Safety of Different Forms and Formulations of AZD9496 in Healthy Subjects

A Phase 1 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target

NCT02780713: Completed Phase 1 study, sponsored by AstraZeneca.

NCT02780713 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02780713, a Phase 1 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target

Study 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.

Primary Outcome

To evaluate maximum observed plasma concentration (Cmax) for AZD9496 and its metabolites M3 and M5 following administration of different AZD9496 formulations and compare with a reference formulation.

Interventions

  • DRUG AZD9496 (Reference)
  • DRUG AZD9496 Variant A
  • DRUG AZD9496 Variant B
  • DRUG AZD9496 Variant C
  • DRUG AZD9496 Variant D

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2016-06-02
Est. Completion 2016-09-20
Phase Phase 1
AstraZeneca

1,285 total trials

What the finished NCT02780713 record still lists

NCT02780713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 5 interventions - of which AZD9496 (Reference) is the first listed.

NCT02780713 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02780713 about?

NCT02780713 is a clinical study titled "A Study to Assess the Pharmacokinetics and Safety of Different Forms and Formulations of AZD9496 in Healthy Subjects". 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...

What is the current status of trial NCT02780713?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2016-06-02. Estimated completion is 2016-09-20.

What interventions are being tested in trial NCT02780713?

The interventions under investigation include: AZD9496 (Reference) (DRUG), AZD9496 Variant A (DRUG), AZD9496 Variant B (DRUG), AZD9496 Variant C (DRUG), AZD9496 Variant D (DRUG).

Who is sponsoring clinical trial NCT02780713?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02780713's enrollment target sits among peer trials

14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02780713, the US trial registry maintained by the National Library of Medicine. NCT02780713 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.