Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors

Summary

This is an open-label, 3-arm, fixed-sequence study to evaluate the effect of single and multiple oral doses of encorafenib in combination with binimetinib on the single oral dose pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme probe substrates using a probe cocktail, on an organic anion-transporting polypeptide/breast cancer resistance protein (OATP/BCRP) substrate using rosuvastatin and on a CYP2B6 substrate using bupropion. The effect of multiple oral doses of the moderate cytochrome P450 (CYP) inhibitor modafinil on encorafenib in combination with binimetinib will also be assessed. The study will have 2 treatment phases, a drug-drug interaction (DDI) phase followed by a post-DDI phase.

Conditions

• Advanced Solid Tumors
• Metastatic Melanoma

Interventions

DRUG

losartan

taken orally

DRUG

dextromethorphan

taken orally

DRUG

caffeine

taken orally

DRUG

omeprazole

taken orally

DRUG

midazolam

taken orally

DRUG

rosuvastatin

taken orally

DRUG

bupropion immediate release (IR)

taken orally

DRUG

encorafenib

taken orally

DRUG

binimetinib

taken orally

DRUG

modafinil

taken orally

Sponsors & Collaborators

• Pierre Fabre Laboratories

  collaborator INDUSTRY

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-02

Primary Completion

2022-07-11

Completion

2023-05-29

FDA Drug

Yes

Countries

• United States
• Belgium
• Canada
• Netherlands
• Spain

Study Locations