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CompletedNCT01116011JMADUpdated Dec 15, 2010

Multiple Ascending Dose Study for AZD 7268 in Japanese Healthy Male Volunteers

A Phase 1 interventional study of AZD7268 and Placebo in Healthy, sponsored by AstraZeneca. Completed at 1 site in Japan. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-15.

Sponsored by AstraZeneca · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • Phase I
  • Japanese Healthy volunteer
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
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    AZD7268

    Drug: AZD7268

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugAZD7268

    Capsule, Oral, BID

  • DrugPlacebo

    Capsule, Oral, BID

06

What researchers measure

Primary outcomes

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

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

Secondary outcomes

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

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

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

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

07

Study locations

1 site
  • Research Site
    Kanagawa, Sagamihara, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01116011
Lead sponsor
AstraZeneca
First posted
May 4, 2010
Start date
Apr 2010
Primary completion
Jul 2010
Completion
Jul 2010
Last update
Dec 15, 2010

Study contacts

Tomoe Fujita
principal investigator · Kitasato University East Hospital, Kanagawa, Japan

Oversight

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

Not currently enrolling

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

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