NCT00696865

CompletedPhase 1

AZD2624 Multiple Ascending Dose Study in Japan

AstraZeneca Source

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Other study identifiers

Sponsor study identifier

D0970C00006

Study Type

interventional

Estimated enrollment

30

Locations

1 country

Sites

1

Timeline

Study Start

May 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

August 2008

Actual (reported)

Brief Summary

This multiple ascending dose study will evaluate safety and tolerability after repeated ascending doses of AZD2624

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 30 participants
Study completion date: August 2008
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 2008
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
June 11, 2008
Actual (reported)
First Posted
June 13, 2008
Actual (reported)
Study Completion
August 2008
Actual (reported)

Last Updated: July 16, 2009
Status Verified: July 2009
Last Update Submitted: July 15, 2009

Conditions

Healthy Safety

Keywords

SafetyTolerabilityPhase I

Outcome Measures

Primary Outcomes (1)

To assess the safety and tolerability of multiple ascending oral doses of AZD2624 in young healthy male Japanese subjects compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEGs
All assessments are made at each visit, at least daily, during the study.

Secondary Outcomes (2)

To evaluate and characterize the pharmacokinetics of AZD2624 and its metabolites when given orally in multiple ascending doses of AZD2624 to young healthy male Japanese subjects by assessment of drug concentration in plasma
Blood samples will be taken before and after study drug administration.
Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD2624
A single blood sample will be obtained

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD2624

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD2624Drug

oral suspension, 3 doses

1

PlaceboDrug

2

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years - 45 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy young male Japanese volunteers

You may not qualify if:

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (1)

Research Site

Kanagawa, Japan

MeSH Terms

Interventions

3-((methylsulfonyl)amino)-2-phenyl-N-(1-phenylpropyl)quinolin-4-carboxamide

Study Officials

Yuji Kumagai, MD, PhD
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

June 11, 2008

First Posted

June 13, 2008

Study Start

May 2008

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

August 2008

Actual (reported)

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Significant illness, as judged by the investigator, within 2 weeks of screening visit or Day 1

Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit or Day 1

Blood loss in excess of 200 mL within 30 days of screening visit or Day 1, in excess of 400 mL within 90 days of screening visit or Day 1, or in excess of 1200 mL within 1 year of screening visit or Day 1

Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator at screening or pre first dose

Contact the study team to confirm eligibility.

Last Updated

July 16, 2009

Record last verified: 2009-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT00696865
Data provider: ClinicalTrials.gov
Source updated: 2009-07-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:54 UTC

Locations

JP(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Study Design

Study Record Dates

Source record

Locations