Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01037725
First received: December 20, 2009
Last updated: July 13, 2010
Last verified: July 2010

December 20, 2009
July 13, 2010
December 2009
Not Provided
Safety and tolerability of AZD5847 administered orally will be assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals [ Time Frame: Safety assessments are taken prior to and after drug administration. Volunteers will be monitored througout the study for adverse events. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01037725 on ClinicalTrials.gov Archive Site
  • To characterize the pharmacokinetics of AZD5847 in blood and urine following oral doses. [ Time Frame: Samples taken during the residential period at defined timepoints pre-dose and post-dose. ] [ Designated as safety issue: Yes ]
  • To assess the effect of food on the pharmacokinetics of AZD5847 following oral administration of AZD5847 [ Time Frame: Samples taken during the residential period at defined timepoints pre-dose and post-dose ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy Volunteers
A Phase-1, Single Center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics (Including Food Effect) of Ascending Oral Doses of AZD5847 in Healthy Male Subjects and Female Subjects of Non-childbearing Potential

The main purpose of this study is to assess the safety and tolerability of AZD5847 after receiving oral doses on a single day (Part A) or after receiving a single oral dose in two periods (Part B). For volunteers in Part B, the effect of food on the PK of AZD5847 will also be studied. Another purpose is to evaluate the pharmacokinetics (PK) of AZD5847 and its metabolites in blood and urine.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: AZD5847

    Part A - Oral doses given to approximately 6 cohorts of 8 subjects (6 on active and 2 on placebo) on Day 1.

    Part B - Oral doses of AZD5847 given to 1 cohort of 8 subjects on Days 1 and 8 in either a fasted state or with a high fat meal

  • Drug: Placebo to AZD5847
    In Part A - Single oral doses of AZD5847placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo) on Day 1
  • Experimental: AZD5847 oral suspension
    Active
    Intervention: Drug: AZD5847
  • Placebo Comparator: Placebo to AZD5847
    Placebo
    Intervention: Drug: Placebo to AZD5847
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
April 2010
Not Provided

Inclusion Criteria:

  • Provision of signed and dated, written informed consent prior to any study specific procedures
  • Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG.
  • Healthy male and female volunteers. Females must be of non childbearing potential

Exclusion Criteria:

  • Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product
  • History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01037725
D3430C00001
No
MSD, AstraZeneca
AstraZeneca
Quintiles
Principal Investigator: Dr. Patricia A Meier, MSc Quintiles
AstraZeneca
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP