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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Ipatasertib; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03222310

GP30057

Details and patient eligibility

About

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).

Enrollment: 15 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Ipatasertib

Experimental group

Description:

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.

Treatment:

Drug: Itraconazole

Drug: Ipatasertib