CompletedNCT00550381Updated Jul 10, 2009

Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy Subjects

A Phase 1 interventional study of HKI-357 in Healthy, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-10.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 72
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study summary

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

Conditions studied

Healthy

Keywords

healthy subjects

In context

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

Eligibility Criteria:

Healthy adult men or women of nonchildbearing potential, aged 18-50.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: Double (Participant, Investigator)
Enrollment: 72 participants (estimated)

Study arms

Placebo comparator
1
10mg
Drug: HKI-357
Placebo comparator
2
20mg
Drug: HKI-357
Placebo comparator
3
40mg
Drug: HKI-357
Placebo comparator
4
80mg
Drug: HKI-357
Placebo comparator
5
160mg
Drug: HKI-357
Placebo comparator
6
240mg
Drug: HKI-357
Placebo comparator
7
400mg
Drug: HKI-357
Placebo comparator
8
640mg
Drug: HKI-357
Placebo comparator
9
960mg
Drug: HKI-357
Placebo comparator
10
placebo
Drug: HKI-357

Interventions

DrugHKI-357
Single-dose capsule

What researchers measure

Primary outcomes

Safety, tolerability, PK
Time frame: 5 days

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 10, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00550381
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: Oct 29, 2007
Start date: Jan 2008
Primary completion: Mar 2008
Completion: Mar 2008
Last update: Jul 10, 2009

Study contacts

Medical Monitor

study director · Wyeth is now a wholly owned subsidiary of Pfizer

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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