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A Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Divarasib in Healthy Participants

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Genentech

Status and phase

Enrolling
Phase 1

Conditions

Healthy Participants

Treatments

Drug: Itraconazole
Drug: Divarasib

Study type

Interventional

Funder types

Industry

Identifiers

NCT06690138
GP45714

Details and patient eligibility

About

This is a Phase 1, open-label, two-period, fixed sequence drug-drug interaction study to evaluate the impact of multiple doses of Itraconazole on the pharmacokinetics (PK) and safety of Divarasib in healthy participants.

Enrollment

18 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Males or females of non-childbearing potential
  • Within body mass index (BMI) range of 18.0 to 32.0 kg/m2, inclusive

Exclusion criteria

  • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
  • Poor peripheral venous access

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

18 participants in 2 patient groups

Treatment A
Experimental group
Description:
Participants will receive a single oral dose of Divarasib on Day 1.
Treatment:
Drug: Divarasib
Treatment B
Experimental group
Description:
Participants will receive Itraconazole twice a day (BID) on Day 1 and once a day (QD) from Day 2 to Day 13. Participants will receive Divarasib in combination with Itraconazole on Day 5.
Treatment:
Drug: Divarasib
Drug: Itraconazole

Trial contacts and locations

1

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Central trial contact

Reference Study ID Number: GP45714 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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