NCT00714337

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

December 10, 2010

Status Verified

December 1, 2010

Enrollment Period

2 months

First QC Date

July 10, 2008

Last Update Submit

December 8, 2010

Conditions

Pharmacokinetics

Keywords

Formulationpharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • PK variables

    Frequent sampling occasions during study days

Secondary Outcomes (1)

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

    During the whole treatment period

Study Arms (5)

1

EXPERIMENTAL

fasting state

Drug: AZD1386

2

EXPERIMENTAL

fasting state

Drug: AZD1386

3

EXPERIMENTAL

non-fasting state

Drug: AZD1386

4

EXPERIMENTAL

fasting state

Drug: AZD1386

5

EXPERIMENTAL

non-fasting state

Drug: AZD1386

Interventions

AZD1386DRUG

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

1

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

AZD1386

Study Officials

  • Klaus Francke, MD

    PAREXEL Clinical Pharmacology Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 10, 2008

First Posted

July 14, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

December 10, 2010

Record last verified: 2010-12