Bioavailability Study Comparing Two New Nilotinib Tablet Formulations to an Established Nilotinib Capsule Formulation in Healthy Volunteers

A Randomized, Open Label, Two-arm, Three Period Crossover Bioavailability Study Comparing Two New Nilotinib Tablet Formulations to an Established Nilotinib Capsule Formulation in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00418769

Enrollment

Registered

2007-01-05

Start date

2006-06-30

Completion date

Unknown

Last updated

2020-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

nilotinib, bioavailability, tablet, capsule, PK, healthy, subject(s),

Brief summary

Bioavailability study comparing two new nilotinib tablet formulations to an established nilotinib capsule formulation in healthy volunteers

Interventions

DRUGNilotinib

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Inclusion 1. Healthy adult male (18 - 55 yrs) and sterile or post menopausal female subjects 2. Body weight must be ≥50 kg and \<100 kg, with a body mass index (BMI) \>18 but \<33. 3. Laboratory parameter values must fall within the normal range Exclusion 1. Female who is pregnant or breast feeding. 2. Contraindication to receiving nilotinib. 3. Smokers or user of tobacco products 4. A past medical history of clinically significant Electrocardiogram abnormalities, or a history/family history of long QT-interval syndrome. Other protocol-defined inclusion/

Exclusion criteria

may apply

Design outcomes

Primary

Measure	Time frame
bioavailability of nilotinib	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026