NCT00787072

Brief Summary

The aim of this study is to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD8075 in healthy male volunteers

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-volunteers

Timeline
Completed

Started Oct 2008

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

October 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

December 2, 2010

Status Verified

November 1, 2010

Enrollment Period

3 months

First QC Date

November 6, 2008

Last Update Submit

November 30, 2010

Conditions

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)

  • PK variables

    Frequent sampling occasions during study days

Study Arms (2)

1

EXPERIMENTAL
Drug: AZD8075

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD8075DRUG

Single dose, the starting dose will be 7 mg, oral suspension, with up to 8 dose escalations not exceeding AstraZeneca pre-defined upper exposure limits.

1
PlaceboDRUG

Oral suspension

2

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.
  • 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:

  • Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject's ability to participate
  • Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs (vital signs (ie, supine BP and pulse) or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk.
  • 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

Uppsala, Sweden

Location

Study Officials

  • Eva Pettersson

    AstraZeneca R&D, Lund, Sweden

    STUDY DIRECTOR

  • Wolfgang Kühn

    Quintiles, Uppsala, 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

November 6, 2008

First Posted

November 7, 2008

Study Start

October 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

December 2, 2010

Record last verified: 2010-11

Locations

SE(1)