NCT01161355

Brief Summary

The primary objective of this study is to assess the absolute bioavailability and to evaluate pharmacokinetic parameters of a single oral dose and a radiolabelled intravenous microdose of \[14C\]AZD9668 in healthy male subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

June 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2010

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 13, 2010

Completed
Last Updated

February 9, 2011

Status Verified

February 1, 2011

Enrollment Period

Same day

First QC Date

June 18, 2010

Last Update Submit

February 8, 2011

Conditions

Healthy

Keywords

Safetytolerabilityhealthymicrodose

Outcome Measures

Primary Outcomes (1)

  • The absolute bioavailability and evaluation of pharmacokinetic parameters (AUC, AUC (0-t), Cmax, t½, tmax, and MRT of of a single oral dose and a radiolabelled intravenous microdose of [14C]AZD9668

    Multiple Pharmacokinetic blood samples for up to 96 hours following drug administration

Secondary Outcomes (1)

  • Safety and tolerability of AZD9668: Adverse events, clinical chemistry, haematology, urinalysis, vital signs, electrocardiogram, physical examination

    measured within 21 days of drug administration and up to 7 days following drug administration

Study Arms (1)

AZD9668

EXPERIMENTAL

Tablets and intravenous (IV) dose

Drug: AZD9668

Interventions

AZD9668DRUG

Tablets of AZD9668 and IV dose of \[C14\]AZD9668

AZD9668

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed and dated, written informed consent prior to any study specific procedures
  • Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weight at least 50 kg and no more than 100 kg.

You may not qualify if:

  • Any clinically significant disease or disorder
  • Any clinically significant abnormalities at screening examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Ruddington, Nottingham, United Kingdom

Location

Research Site

London, United Kingdom

Location

MeSH Terms

Interventions

N-((5-(methanesulfonyl)pyridin-2-yl)methyl)-6-methyl-5-(1-methyl-1H-pyrazol-5-yl)-2-oxo-1-(3-(trifluoromethyl)phenyl)-1,2-dihydropyridine-3-carboxamide

Study Officials

  • Joanna Marks-Konczalik

    AstraZeneca

    STUDY DIRECTOR

  • Sharan Sidhu, MB ChB, BAO,

    Quintiles, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 18, 2010

First Posted

July 13, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

February 9, 2011

Record last verified: 2011-02

Locations

GB(2)