NCT00918398

Brief Summary

The primary objective is to investigate the pharmacokinetics of AZD1981 given in different formulations and to measure renal clearance

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_1 healthy

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

June 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

July 30, 2009

Status Verified

July 1, 2009

First QC Date

June 10, 2009

Last Update Submit

July 29, 2009

Conditions

HealthyPostmenopausalSurgically Sterile Women

Outcome Measures

Primary Outcomes (1)

  • PK samples for AZD1981 from both blood and urine

    Intense PK-sampling during the 24 hours following dose and additional samples up to 60 hours after dose.

Secondary Outcomes (1)

  • Safety variables (adverse events and laboratory safety lab)

    Adverese events registered during study and vital signs and ECG at visit 1,2 ,6

Study Arms (4)

1

EXPERIMENTAL

AZD1981, 100 mg iv infusion

Drug: AZD1981

2

EXPERIMENTAL

AZD1981, 514 mg oral solution

Drug: AZD1981

3

EXPERIMENTAL

AZD1981, 500 mg oral tablet A

Drug: AZD1981

4

EXPERIMENTAL

AZD1981, 500 mg oral tablet B

Drug: AZD1981

Interventions

AZD1981DRUG

100 mg iv infusion, single dose, 4 hours infusion

1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of informed consent prior to any study specific procedures
  • Men or post-menopausal or surgically sterile women, aged 18 to 55 years
  • Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
  • Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to Visit 1 (pre-entry)

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 phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Uppsala, Sweden

Location

MeSH Terms

Interventions

AZD1981

Study Officials

  • Eva Pettersson

    AstraZeneca R&D, Lund, Sweden

    STUDY DIRECTOR

  • Elisabeth Eden

    Quintiles AB, Uppsala, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 10, 2009

First Posted

June 11, 2009

Study Start

June 1, 2009

Study Completion

July 1, 2009

Last Updated

July 30, 2009

Record last verified: 2009-07

Locations

SE(1)