NCT01116011

Brief Summary

This is a multiple ascending dose study (MAD) in the Japanese population with AZD7268. This MAD study will evaluate the safety, tolerability and pharmacokinetics of orally administered AZD7268 after multiple ascending doses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2010

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

December 15, 2010

Status Verified

November 1, 2010

Enrollment Period

3 months

First QC Date

April 13, 2010

Last Update Submit

December 14, 2010

Conditions

Healthy

Keywords

Phase IJapanese Healthy volunteer

Outcome Measures

Primary Outcomes (1)

  • Investigate the safety and tolerability of AZD7268 by Adverse Events.

    From first dosing throughout the treatment period and including the follow-up period

Secondary Outcomes (2)

  • Characterize the PK parameters(Cmax, AUC,t1/2) of AZD7268 by assessment of drug concentrations in plasma

    Blood samples will be taken from pre-dose until 48 hours post last dose

  • Characterize the PK parameters (CLr, Ae) of AZD7268 by assessment of drug concentrations in urine

    Urine samples will be taken from post first dose until 48 hours post last dose.

Study Arms (2)

AZD7268

EXPERIMENTAL
Drug: AZD7268

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD7268DRUG

Capsule, Oral, BID

AZD7268
PlaceboDRUG

Capsule, Oral, BID

Placebo

Eligibility Criteria

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

You may qualify if:

  • Provision of Informed Consent
  • Healthy male subjects, with suitable veins for cannulation or repeated venipuncture

You may not qualify if:

  • Inability to understand or cooperate with given information
  • Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, Hepatitis C and syphilis test
  • History of seizure (including infant febrile seizures) or family history of seizure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Kanagawa, Sagamihara, Japan

Location

Study Officials

  • Tomoe Fujita

    Kitasato University East Hospital, Kanagawa, Japan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 13, 2010

First Posted

May 4, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

December 15, 2010

Record last verified: 2010-11

Locations

JP(1)