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A Study to Evaluate the Effect of a Potent Cytochrome P450 (CYP) 3A Inhibitor on Ipatasertib

NCT ID: NCT03222310

Last Updated: 2017-11-09

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-18

Study Completion Date

2017-09-06

Brief Summary

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This study will be a single center, open-label, 2-period, fixed-sequence, Phase 1 drug-drug interaction study in healthy subjects. The primary purpose of this study is to evaluate the effect of itraconazole on the PK of ipatasertib and its primary metabolite (G-037720).

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ipatasertib

Participants will receive one 100 milligram (mg) ipatasertib tablet orally on Day 1 of treatment in treatment period 1 followed by two 100 mg itraconazole capsules orally on Days 15 to 23 along with one 100 mg of ipatasertib on Day 19 in treatment period 2. Both the treatment period will be separated by a washout period of 14 days.

Group Type EXPERIMENTAL

Ipatasertib

Intervention Type DRUG

Ipatasertib 100 mg tablet orally once daily.

Itraconazole

Intervention Type DRUG

Itraconazole 100 mg capsules orally once daily.

Interventions

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Ipatasertib

Ipatasertib 100 mg tablet orally once daily.

Intervention Type DRUG

Itraconazole

Itraconazole 100 mg capsules orally once daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Within body mass index (BMI) range 18.5 to 32.0 kg/m2, inclusive
* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
* Clinical laboratory evaluations (including chemistry panel \[fasted at least 8 hours\], hematology, and urinalysis \[UA\] with complete microscopic analysis within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator)
* Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check-in (Day -2)
* Negative hepatitis panel (hepatitis B surface antigen and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) antibody screens

Exclusion Criteria

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder (as determined by the Investigator)
* History of diabetes requiring insulin or fasting glucose ≥160 mg/dL
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
* history of stomach or intestinal surgery or resection, or other GI disorder that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy, hernia repair, and/or cholecystectomy will be allowed
* history or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Covance Research Unit - Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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GP30057

Identifier Type: -

Identifier Source: org_study_id