Clinical trial NCT03290703: A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Healthy Participants
Official title: A Phase I, Single Center, Randomized, Open-Label Study Investigating the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics of GDC-0853 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-25
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the PK of GDC-0853 following changes to formulation and in the presence or absence of food, the proton pump inhibitor (rabeprazole), or both. This will be a 3-part open-label randomized study conducted in healthy adult participants. Approximately 63 subjects will be enrolled in this study.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female (of non-childbearing potential) participants
* Within body mass index range 18.0 to 32.0 kilogram per meter square (kg/m\^2), inclusive
* In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs and physical examinations
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria:

* History or symptoms of any significant disease
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
* History of stomach or intestinal surgery or resection
* Participants who previously participated in any other investigational study drug trial within 90 days prior to Check-in. Participants who previously received GDC-0853 in previous studies.
* History of malignancy
* Pregnancy, lactation, or breastfeeding in female participants

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of GDC-0853
timeFrame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of GDC-0853
timeFrame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Area Under the Curve From Time Zero to Last Measurable Concentration [AUC (0-t)] of GDC-0853
timeFrame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of GDC-0853
timeFrame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Extrapolated Area Under the Curve (AUC Percent [%] Extrap) of GDC-0853
timeFrame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Apparent Terminal Elimination Rate Constant of GDC-0853
timeFrame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Apparent Volume of Distribution (Vz/F) of GDC-0853
timeFrame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Apparent Oral Clearance (CL/F) of GDC-0853
timeFrame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Relative Bioavailability (Frel) of GDC-0853
timeFrame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Apparent Terminal Elimination Half-Life (t1/2) of GDC-0853
timeFrame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
Secondary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: From screening to the end of the study (approximately a maximum of 11 weeks)
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical Ltd, Clinical Research Unit
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trial
role: STUDY_DIRECTOR
References: