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CompletedNCT00714337Updated Dec 10, 2010

Formulation and Food Effect Study of AZD1386 in Healthy Volunteers

A Phase 1 interventional study of AZD1386 and AZD1386 in Pharmacokinetics, sponsored by AstraZeneca. Completed. 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

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study summary

To investigate the pharmacokinetics of two oral solid formulations of AZD1386 in relation to the AZD1386 oral solution.

02

Conditions studied

  • Pharmacokinetics

Keywords

  • Formulation
  • pharmacokinetics
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

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04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Females must be non-fertile (Amenorrhea and no pregnancy in the last 12 months prior to enrolment or documentation of being irreversible surgically sterile).
  • Healthy male volunteers with BMI between 18 and 30 kg/m2
  • Clinical normal physical findings, including blood pressure, pulse rate above 45 bpm, ECG, and laboratory assessments.
  • Normal QTc interval on baseline ECG, between 360-450 msec, according to the Fridericia formula.

Exclusion criteria

Exclusion Criteria:

  • History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity as judged by the Investigator.
  • Requirement of concomitant medication during the study, excluding hormone replacement therapy (HRT) or use of drugs with enzyme inducing properties with 3 weeks of first dose
  • Smoking more than 7 cigarettes per week or consumption of more than 3 portion of snuff or equivalent per day within 30 days before first administration of study drug
  • A family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives and who have a QT/QTc \<360 ms
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    1

    fasting state

    Drug: AZD1386

  • Experimental
    2

    fasting state

    Drug: AZD1386

  • Experimental
    3

    non-fasting state

    Drug: AZD1386

  • Experimental
    4

    fasting state

    Drug: AZD1386

  • Experimental
    5

    non-fasting state

    Drug: AZD1386

Interventions

  • DrugAZD1386

    One single oral dose of 90mg (36mL of AZD1386 2.5mg/mL oral solution).

  • DrugAZD1386

    One single oral dose of 90mg (3 x 30mg AZD1386 capsules)

  • DrugAZD1386

    One single oral dose of 90mg (6 x 15mg AZD1386 tablets)

06

What researchers measure

Primary outcomes

  1. PK variables

    Time frame: Frequent sampling occasions during study days

Secondary outcomes

  1. Safety variables (adverse events, blood pressure, pulse, safety lab)

    Time frame: During the whole treatment period

07

Study locations

No study locations are listed for this record.

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
NCT00714337
Lead sponsor
AstraZeneca
First posted
Jul 14, 2008
Start date
Jun 2008
Primary completion
Aug 2008
Completion
Aug 2008
Last update
Dec 10, 2010

Study contacts

Klaus Francke, MD
principal investigator · PAREXEL Clinical Pharmacology Research Unit

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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