Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy Subjects
Status and phase
Completed
Phase 1
Conditions
Healthy
Treatments
Drug: HKI-357
Details and patient eligibility
About
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single doses of HKI-357 administered to healthy subjects.
Enrollment
72 estimated patients
Sex
All
Ages
18 to 50 years old
Volunteers
Accepts Healthy Volunteers
Inclusion and exclusion criteria
Eligibility Criteria:
- Healthy adult men or women of nonchildbearing potential, aged 18-50.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Single Group Assignment
Masking
Double Blind
72 participants in 10 patient groups, including a placebo group
1
Placebo Comparator group
Description:
10mg
Treatment:
Drug: HKI-357
2
Placebo Comparator group
Description:
20mg
Treatment:
Drug: HKI-357
3
Placebo Comparator group
Description:
40mg
Treatment:
Drug: HKI-357
4
Placebo Comparator group
Description:
80mg
Treatment:
Drug: HKI-357
5
Placebo Comparator group
Description:
160mg
Treatment:
Drug: HKI-357
6
Placebo Comparator group
Description:
240mg
Treatment:
Drug: HKI-357
7
Placebo Comparator group
Description:
400mg
Treatment:
Drug: HKI-357
8
Placebo Comparator group
Description:
640mg
Treatment:
Drug: HKI-357
9
Placebo Comparator group
Description:
960mg
Treatment:
Drug: HKI-357
10
Placebo Comparator group
Description:
placebo
Treatment:
Drug: HKI-357
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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