NCT00550381

Brief Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single doses of HKI-357 administered to healthy subjects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_1 healthy

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

First Submitted

Initial submission to the registry

October 26, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 29, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

July 10, 2009

Status Verified

July 1, 2009

Enrollment Period

2 months

First QC Date

October 26, 2007

Last Update Submit

July 8, 2009

Conditions

Healthy

Keywords

healthy subjects

Outcome Measures

Primary Outcomes (1)

  • Safety, tolerability, PK

    5 days

Study Arms (10)

1

PLACEBO COMPARATOR

10mg

Drug: HKI-357

2

PLACEBO COMPARATOR

20mg

Drug: HKI-357

3

PLACEBO COMPARATOR

40mg

Drug: HKI-357

4

PLACEBO COMPARATOR

80mg

Drug: HKI-357

5

PLACEBO COMPARATOR

160mg

Drug: HKI-357

6

PLACEBO COMPARATOR

240mg

Drug: HKI-357

7

PLACEBO COMPARATOR

400mg

Drug: HKI-357

8

PLACEBO COMPARATOR

640mg

Drug: HKI-357

9

PLACEBO COMPARATOR

960mg

Drug: HKI-357

10

PLACEBO COMPARATOR

placebo

Drug: HKI-357

Interventions

HKI-357DRUG

Single-dose capsule

11023456789

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Eligibility Criteria: * Healthy adult men or women of nonchildbearing potential, aged 18-50.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 26, 2007

First Posted

October 29, 2007

Study Start

January 1, 2008

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

July 10, 2009

Record last verified: 2009-07