NCT00713271

Brief Summary

The purpose of this study is to investigate the safety and tolerability of multiple once daily ascending doses of AZD3199 in healthy men

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Aug 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

First Submitted

Initial submission to the registry

July 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2008

Completed
21 days until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

April 10, 2014

Status Verified

April 1, 2014

Enrollment Period

3 months

First QC Date

July 9, 2008

Last Update Submit

April 9, 2014

Conditions

Healthy Volunteers

Keywords

Healthy maletolerabilitysafetyinhalation

Outcome Measures

Primary Outcomes (2)

  • Incidence and nature of Adverse Events

    Before, during and after dosing

  • Clinical significant abnormalities in ECG, pulse, blood pressure, lung function, temp, lab

    Before, during and after dosing

Secondary Outcomes (3)

  • Pharmacokinetics

    Before, during and after dosing

  • Potassium and lactate concentrations

    Before, during and after dosing

  • Tremor, palpitations, heart rate, QTc, pulse and blood pressure and FEV1

    Before, during and after dosing

Study Arms (4)

1

EXPERIMENTAL

Low dose

Drug: AZD3199

2

EXPERIMENTAL

intermediate dose

Drug: AZD3199

3

EXPERIMENTAL

high dose

Drug: AZD3199

4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD3199DRUG

Low dose Dry powder for inhalation, o.d., 1+12 days

1
PlaceboDRUG
4

Eligibility Criteria

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

You may qualify if:

  • BMI 19-30, weight 60-100 kg
  • Non/ex-smokers, Non/ex-nicotine users

You may not qualify if:

  • Any clinically significant disease or disorder
  • Any clinically relevant abnormal findings at screening examinations
  • Use of any prescribed or non-prescribed medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Lund, Sweden

Location

Related Links

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

AZD-3199

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gabriella Samuelsson Palmgren

    AZ CPU Lund, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2008

First Posted

July 11, 2008

Study Start

August 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

April 10, 2014

Record last verified: 2014-04

Locations

SE(1)