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Completed

NCT Number: NCT01348737

Assessment of Safety, Tolerability and Blood Concentrations of Single Doses of AZD3839 in Healthy Volunteers

The purpose of the study is to assess the safety, tolerability and blood concentration of AZD3839 following oral administration of single doses in healthy men and women of non-childbearing potential

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and female volunteers of non-childbearing potential aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture
  • Have a body mass index (BMI) between 19 and 30 kg/m2 (inclusive) and weigh between 50 kg and 100 kg (inclusive)
  • Creatinine clearance in the normal range (>80 mL/min estimated according to Cockroft-Gault)
  • Healthy volunteers should have a serum potassium concentration of ≥3.8 mmol/L at screening (Visit 1) and on admission to the study centre (Day -1)
  • Clinically normal findings on physical examination in relation to age, as judged by the Investigator

Exclusion criteria

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the healthy volunteer at risk because of participation in the study, or influence the results or the healthy volunteer's ability to participate in the study
  • History of psychotic disorder amongst first degree relatives
  • Significant orthostatic reaction at enrolment as judged by the Investigator
  • Prolonged QTcF greater than 450 msec or shortened QTcF less than 340 msec or family history of long QT syndrome or sudden death
  • Healthy volunteer is a vegetarian/lactose intolerant (exclusion criterion only applicable for healthy volunteers participating in Part 2

Treatment and study plan

AZD3839

Drug

Single Oral Dose

AZD3839 Placebo

Drug

Single Oral Dose

Primary outcomes

  1. Number of Adverse Event as a measure of safety and tolerability of AZD3839 (Part 1)

    Time frame: Part 1 - AEs will be collected from admission to the study centre (Visit 2, Day-1) until the follow-up visit (Visit 3) approximately 15 days

  2. Number of Adverse Events as a measure of Safety and tolerability of AZD3839 (Part 2)

    Time frame: Part 2 - AEs will be collected from admission to the study centre (Visit 2, Day-1) until the follow-up visit (Visit 4) approximately 20 days

Secondary outcomes

  1. Time at which maximum concentration occurs in AZD3839 (Part 1)

    Time frame: pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after the administration of the investigational product, as well as on Day 4 and at the follow-up visit (Visit 3)

  2. Maximum observed concentration of AZD3839 in plasma (Part 1)

    Time frame: Part 1 - pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after the administration of the investigational product, as well as on Day 4 and at the follow-up visit (Visit 3)

  3. Time at which maximum concentration occurs in AZD3839 (Part 2)

    Time frame: Part 2 - at pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after the Administration. May be taken at the follow-up visit (Visit 4)

  4. Maximum observed concentration of AZD3839 in plasma (Part 2)

    Time frame: Part 2 - at pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after administration

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Biomarkers of AZD3839 Including an Open-label Food Effect Group in Healthy Male and Female Volunteers of Non-childbearing Potential

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 5, 2011
Registry last updated
Apr 6, 2012

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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