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

NCT ID: NCT00418769

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nilotinib Tablet Formulations

Group Type EXPERIMENTAL

Nilotinib

Intervention Type DRUG

Established Nilotinib Capsule Formulation

Group Type ACTIVE_COMPARATOR

Nilotinib

Intervention Type DRUG

Interventions

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Nilotinib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2498

Results for CAMN107A2117 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CAMN107A2117

Identifier Type: -

Identifier Source: org_study_id