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TerminatedNCT00945178Updated Dec 10, 2010

Double-blind Placebo-controlled 2-part Study Assessing the Safety, Tolerability and PK of AZD1386 in Healthy Volunteers

A Phase 1 interventional study of AZD1386 and Placebo for AZD1386 in Healthy Volunteers, sponsored by AstraZeneca. Terminated at 1 site in United Kingdom. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-10.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Why this study was terminated
The study was terminated due to results in another study (NCT00878501).
Phase
Phase 1
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study summary

The study will investigate how a new formulation of the study drug is absorbed, metabolised and distributed through the body, as well as its safety and tolerability in higher doses when given as single and multiple doses and as a single dose in the presence and absence of naproxen.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Safety
  • Tolerability
  • Healthy
  • Pharmacokinetics
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Provision of signed, written and dated informed consent prior to any study specific procedures
  • Healthy male and female (of non childbearing potential)
  • Body Mass Index (BMI) of ≥19 to ≤28 kg/m2 and a weight of ≥50 to ≤100 kg

Exclusion criteria

Exclusion Criteria:

  • History or presence of any clinically significant disease or disorder in the opinion of the investigator.
  • Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Part A: A

    AZD1386

    Drug: AZD1386

  • Experimental
    Part A: B

    Placebo for AZD1386

    Drug: Placebo for AZD1386

  • Experimental
    Part B: A

    Naproxen

    Drug: Naproxen

  • Experimental
    Part B: B

    Placebo for Naproxen

    Drug: Placebo for Naproxen

Interventions

  • DrugAZD1386

    Single ascending and multiple (twice daily) oral doses, capsule

  • DrugPlacebo for AZD1386

    Single ascending and multiple (twice daily) oral doses, capsule

  • DrugNaproxen

    Tablet, single oral dose, 500mg

  • DrugPlacebo for Naproxen

    Tablet, single oral dose

06

What researchers measure

Primary outcomes

  1. Safety variables (adverse events, vital signs, ECG, safety lab)

    Time frame: Assessments performed at frequent timepoints (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 3 (Part A: treatment period 1 and Part B) or Day-1 to Day 9 (Part A: treatment period 2) and at follow-up 4-14 days after discharge.

Secondary outcomes

  1. To characterize the pharmacokinetics of AZD1386 in plasma

    Time frame: Assessments performed at frequent timepoints (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 3 (Part A: treatment period 1 and Part B) or Day-1 to Day 9 (Part A: treatment period 2).

07

Study locations

1 site
  • Research Site
    Harrow, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00945178
Lead sponsor
AstraZeneca
First posted
Jul 24, 2009
Start date
Aug 2009
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Dec 10, 2010

Study contacts

Richard Leff
study director · AstraZeneca Pharmaceuticals, Wilmington, UK
Dr. Tania Hugo
principal investigator · PAREXEL Early Phase Clinical Unit, London UK.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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