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A Drug-Drug Interaction Study of the Effect of Rabeprazole, Itraconazole or Fluconazole on the Pharmacokinetics of Vismodegib

NCT ID: NCT01772290

Last Updated: 2016-11-02

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

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-05-31

Brief Summary

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This randomized, open-label, 4-arm, multiple-dose study will evaluate the effect of coadministration of a protein pump inhibitor, an inhibitor of P-glycoprotein and CYP3A4, or an inhibitor of CYP2C9 on the pharmacokinetics of vismodegib in healthy female subjects of non-childbearing potential. Subjects will be randomized to receive multiple oral doses of vismodegib, alone or in combination with multiple oral doses of either rabeprazole, itraconazole or fluconazole. Anticipated time on study treatment is up to 11 days.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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A: Vismodegib

Group Type ACTIVE_COMPARATOR

vismodegib

Intervention Type DRUG

Multiple oral doses

B: Rabeprazole + Vismodegib

Group Type EXPERIMENTAL

rabeprazole

Intervention Type DRUG

Multiple oral doses

vismodegib

Intervention Type DRUG

Multiple oral doses

C: Itraconazole + Vismodegib

Group Type EXPERIMENTAL

itraconazole

Intervention Type DRUG

Multiple oral doses

vismodegib

Intervention Type DRUG

Multiple oral doses

D: Fluconazole + Vismodegib

Group Type EXPERIMENTAL

fluconazole

Intervention Type DRUG

Multiple oral doses

vismodegib

Intervention Type DRUG

Multiple oral doses

Interventions

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fluconazole

Multiple oral doses

Intervention Type DRUG

itraconazole

Multiple oral doses

Intervention Type DRUG

rabeprazole

Multiple oral doses

Intervention Type DRUG

vismodegib

Multiple oral doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Females of non-childbearing potential
* Body mass index (BMI) 18 to 32 kg/m2, inclusive
* In good health, determined by no clinically significant findings from medical history, physical examination. 12-lead ECG, and vital signs
* Clinical laboratory evaluations, complete blood count and urinalysis within the normal range for the test laboratory, unless not deemed clinically significant by the investigator
* Negative test for drugs of abuse at screening and check-in (including alcohol)
* Negative for hepatitis B, hepatitis C and HIV infection
* Non-childbearing potential is defined as: non-pregnant, non-lactating, and either postmenopausal for at least 1 year or surgically sterile (e.g. bilateral oophorectomy and/or hysterectomy)

Exclusion Criteria

* Significant history or clinical evidence of any metabolic (including type 1 or 2 diabetes). allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, endocrine, GI (including gastric or duodenal ulcers), Zollinger-Ellison syndrome, Barrett's esophagus, urological, neurological, or psychiatric disorder
* History of inflammatory arthritis
* History of symptomatic hypotension
* History of seizure disorders
* History of bipolar or major depressive disorder
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (appendectomy, hernia repair, and/or cholecystectomy will be allowed)
* History of alcoholism or drug addiction within 1 year prior to check-in
* Use of any tobacco- or nicotine-containing products within 6 months prior to check-in
* Participation in any other investigational study drug or biological agent trial in which receipt of investigational study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to check-in
* Use of PPIs, H2-receptor antagonists, or antacids within 1 month prior to check-in
* History of chronic PPI use (\> 30 days of continuous daily dosing) within 6 months of check-in
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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Daytona Beach, Florida, United States

Site Status

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Malhi V, Colburn D, Williams SJ, Hop CE, Dresser MJ, Chandra P, Graham RA. A clinical drug-drug interaction study to evaluate the effect of a proton-pump inhibitor, a combined P-glycoprotein/cytochrome 450 enzyme (CYP)3A4 inhibitor, and a CYP2C9 inhibitor on the pharmacokinetics of vismodegib. Cancer Chemother Pharmacol. 2016 Jul;78(1):41-9. doi: 10.1007/s00280-016-3020-z. Epub 2016 May 6.

Reference Type DERIVED
PMID: 27154174 (View on PubMed)

Other Identifiers

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GP28465

Identifier Type: -

Identifier Source: org_study_id