NCT00967356

Brief Summary

The aims of this study are to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD5985 in healthy male subjects.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

November 13, 2009

Status Verified

November 1, 2009

First QC Date

August 26, 2009

Last Update Submit

November 11, 2009

Conditions

Healthy

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

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

    Frequent sampling occasions during study days

Secondary Outcomes (1)

  • Pharmacokinetic variables

    Frequent sampling occasions during study days

Study Arms (2)

A

EXPERIMENTAL

AZD5985

Drug: AZD5985

B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AZD5985DRUG

Single dose-The starting dose will be 40 mg, oral suspension, with up to 8 dose escalations not exceeding AstraZeneca predefined 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 procedure
  • Healthy male subjects aged 18 to 45 years (inclusive)
  • Have a body mass index (BMI) between 18 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 methodological study (no drug) 1 month prior to Visit 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Gothenburg, Sweden

Location

Study Officials

  • Eva Pettersson

    AstraZeneca R&D, Lund, Sweden

    STUDY DIRECTOR

  • Marianne Hartford

    AstraZeneca R&D, Mölndal, Sweden

    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

August 26, 2009

First Posted

August 27, 2009

Study Start

August 1, 2009

Study Completion

November 1, 2009

Last Updated

November 13, 2009

Record last verified: 2009-11

Locations

SE(1)