NCT01046357

Brief Summary

This is a Phase I, first time in human, randomised, blinded, placebo-controlled, single ascending dose study in healthy male volunteers conducted at a single centre. The effect of food on the pharmacokinetics of AZD7687 will also be studied. The study will consist of two parts, a dose escalation part and a food interaction part. The two parts will be run in parallel. In total, 64 healthy volunteers divided in 8 different panels (8 volunteers per cohort) will be exposed to single doses during the dose escalation. Each subject will receive dose only once, except for the volunteers included in the dose steps repeated for food interaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Nov 2009

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

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

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
5 months 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
Last Updated

February 13, 2012

Status Verified

February 1, 2012

Enrollment Period

7 months

First QC Date

December 3, 2009

Last Update Submit

February 10, 2012

Conditions

Healthy

Keywords

First in humanSafety

Outcome Measures

Primary Outcomes (1)

  • Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments)

Secondary Outcomes (3)

  • Plasma concentrations of AZD7687 and plasma pharmacokinetic parameters.

  • Exploratory pharmacogenetic blood sampling.

  • Pharmacodynamic biomarker sampling; blood samples.

Study Arms (2)

Active

EXPERIMENTAL

AZD7687 oral suspension

Drug: AZD7687

Placebo

EXPERIMENTAL

placebo oral suspension

Drug: Placebo

Interventions

AZD7687DRUG

Single oral dose

Active
PlaceboDRUG

Single oral dose

Placebo

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • BMI between 19-30

You may not qualify if:

  • No blood donation prior 30 days
  • No other clinical study prior 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

AZD7687

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2009

First Posted

January 12, 2010

Study Start

November 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

February 13, 2012

Record last verified: 2012-02

Locations

US(1)