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Completed

NCT Number: NCT01254461

A Drug-Drug Interaction Study Between AZD1981 and Pravastatin to Study the Effect of AZD1981 on the Kinetics of Pravastatin

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

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Key information

Conditions

Drug Interaction

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

AZD1981

Drug

100 mg per oral, twice daily for 8 days

Pravastatin

Drug

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

Other names: pravachol

Primary outcomes

  1. Pharmacokinetics for pravastatin measured by Cmax and AUC

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

    Pharmacokinetics for pravastatin measured by Cmax and AUC

Secondary outcomes

  1. AUC

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

    Pharmacokinetics for pravastatin measured by AUC[0-t],Cmax (tmax), CL/F, t1/2λz, Vz/F, MRT

  2. AUCτ

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

    Pharmacokinetics for AZD1981 measured by AUCτ,Css,max, Css, max (tmax ss), CLss/F, t1/2λz, Vz/F, MRT

  3. Safety and tolerability

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

    Safety and tolerability of AZD1981

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Open Label, Randomised, Parallel Group Study of Repeated Oral Doses of AZD1981 (100 mg Twice Daily and 400 mg Twice Daily Via Tablet) for Eight Days and Single Doses of Pravastatin (Pravachol® Tablet 40 mg) to Evaluate the Pharmacokinetic Interaction of AZD1981 and Pravastatin in Healthy Male Volunteers

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 6, 2010
Registry last updated
Apr 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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