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OpenTrials
Completed

NCT Number: NCT01097408

Pharmacokinetics of AZD7295 Capsules

This is a pharmacokinetics (PK) and safety study of AZD7295 in healthy volunteers.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical Research

Nottingham, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male or female volunteers, aged 18-65 years.

Exclusion criteria

  • Previous exposure to AZD7295, clinically relevant disease.

Treatment and study plan

AZD7295

Drug

Up to 650mg AZD7295 capsules per dose. To be given 2 or 3 times daily for 5 days.

placebo comparator

Drug

Placebo capsules

Primary outcomes

  1. Pharmacokinetics of AZD7295 capsules

    Time frame: 0-72h after each dose

    PK parameters of AZD7295 will be measured after single and repeated doses (AUC, Cmax, t1/2)

Secondary outcomes

  1. Safety and tolerability of AZD7295 capsules

    Time frame: 0-72h after each dose

    Safety and tolerability of AZD7295 will be assessed after single and repeated doses (adverse events, ECGs, vital signs, safety laboratory tests)

Sponsors and collaborators

Lead sponsor

Arrow Therapeutics

Industry

Registry information

Official study title

A Randomised, Double-Blind, Placebo-Controlled Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD7295 Capsules in Healthy Volunteers

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 1, 2010
Registry last updated
Aug 9, 2010

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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