NCT01097408

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Mar 2010

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

March 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

August 9, 2010

Status Verified

August 1, 2010

Enrollment Period

2 months

First QC Date

March 30, 2010

Last Update Submit

August 6, 2010

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of AZD7295 capsules

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

    0-72h after each dose

Secondary Outcomes (1)

  • Safety and tolerability of AZD7295 capsules

    0-72h after each dose

Study Arms (2)

AZD7295

EXPERIMENTAL
Drug: AZD7295

Matched placebo

PLACEBO COMPARATOR
Drug: Placebo comparator

Interventions

AZD7295DRUG

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

AZD7295
Placebo comparatorDRUG

Placebo capsules

Matched placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Previous exposure to AZD7295, clinically relevant disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Clinical Research

Nottingham, United Kingdom

Location

Study Officials

  • Jo Collier, Mb ChB

    Quotient Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 30, 2010

First Posted

April 1, 2010

Study Start

March 1, 2010

Primary Completion

May 1, 2010

Study Completion

August 1, 2010

Last Updated

August 9, 2010

Record last verified: 2010-08

Locations

GB(1)