NCT01254461

Brief Summary

The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the pharmacokinetics of pravastatin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_1

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

December 3, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

April 29, 2011

Status Verified

April 1, 2011

Enrollment Period

2 months

First QC Date

December 3, 2010

Last Update Submit

April 28, 2011

Conditions

Drug Interaction

Keywords

Phase 1Drug-Drug interactionpravastatinAZD1981The pharmacokinetics resulting from AZD1981 and pravastatin interactionThe effects of taking a combination of AZD1981 and pravastatin

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics for pravastatin measured by Cmax and AUC

    Pharmacokinetics for pravastatin measured by Cmax and AUC

    Pharmacokinetic (PK) sampling will be performed on Day 1, period A and on Day 7-8, period B

Secondary Outcomes (3)

  • AUC

    PK sampling will be performed on Day 1, period A and on Day 7-8, period B

  • AUCτ

    PK sampling will be performed on Day 7 and Day 8, period B

  • Safety and tolerability

    Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study

Study Arms (2)

A

EXPERIMENTAL
Drug: AZD1981Drug: pravastatin

B

EXPERIMENTAL
Drug: AZD1981Drug: pravastatin

Interventions

AZD1981DRUG

100 mg per oral, twice daily for 8 days

A
pravastatinDRUG

40 mg, once daily at Day 1, period A and Day 8, period B

Also known as: pravachol
AB

Eligibility Criteria

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

You may qualify if:

  • Healthy male volunteers aged 18 to 55, inclusive
  • Have a body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg, inclusive
  • Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to screening
  • Volunteers must be willing to use barrier methods of contraception during study and 3 months after the end of their participation in the study

You may not qualify if:

  • Any clinically significant disease or disorder
  • Any clinically relevant abnormal findings in physical examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Uppsala, Sweden

Location

MeSH Terms

Interventions

AZD1981Pravastatin

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

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

Study Record Dates

First Submitted

December 3, 2010

First Posted

December 6, 2010

Study Start

February 1, 2011

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 29, 2011

Record last verified: 2011-04

Locations

SE(1)