NCT00799331

Brief Summary

The aim of this exploratory study is to assess the pharmacokinetics of increasing oral doses of AZD5985 in healthy male volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 2008

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

November 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

June 9, 2009

Status Verified

June 1, 2009

Enrollment Period

3 months

First QC Date

November 21, 2008

Last Update Submit

June 8, 2009

Conditions

Healthy

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • It is the objective of this exploratory study to assess pharmacokinetics of AZD5985 following administration of single increasing doses. The primary variable is plasma concentration of AZD5985.

    Frequent sampling occasions during study days

Study Arms (2)

A

EXPERIMENTAL

AZD5985

Drug: AZD5985

B

EXPERIMENTAL

placebo

Drug: placebo

Interventions

AZD5985DRUG

Oral suspension. Single oral doses of AZD5985 starting with 4 mg and subsequently with up to 3 dose escalations will be administered not exceeding AstraZeneca pre-defined upper exposure limits.

A
placeboDRUG

Oral suspension.

B

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of signed, written and dated informed consent prior to any study specific procedures.
  • Healthy male subjects aged 18 to 45 years (inclusive).
  • Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
  • Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start.

You may not qualify if:

  • History or presence of any clinically significant disease or disorder in the opinion of the investigator.
  • Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
  • Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Berlin, Germany

Location

Study Officials

  • Eva Pettersson

    AstraZeneca R&D, Lund, Sweden

    STUDY DIRECTOR

  • Maura Fallon

    Parexel, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 21, 2008

First Posted

November 27, 2008

Study Start

November 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

June 9, 2009

Record last verified: 2009-06

Locations

DE(1)