A study to compare how much of divarasib is absorbed after a single oral dose of two different tablet formulations in healthy participants

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2024
INTERVENTION: Participants will be randomized according to a randomization schedule generated by a Fortrea biostatistician. Treatment A, followed by treatment B: Participants will first receive divarasib, 400 mg as a single 400 mg tablet (treatment A), orally, under fasted conditions on Day 1 of Period 1. After a 7‐day washout period, participants will then receive 400 mg of divarasib, as two tablets of 200 mg each (treatment B), orally, under fasted conditions on Day 1 of Period 2. Treatment B, followed by treatment A: Participants will first receive 400 mg of divarasib, as two tablets of 200 mg each (treatment B), orally, under fasted conditions on Day 1 of Period 1. After a 7‐day washout period, participants will receive divarasib, 400 mg as a single 400 mg tablet (treatment A), orally, under fasted conditions on Day 1 of Period 2. CONDITION: Healthy participants ; Not Applicable PRIMARY OUTCOME: 1. Pharmacokinetic (PK) parameters of divarasib measured using blood samples collected over 5 days on periods 1 and 2. The following PK parameters will be calculated if data allows:; 1.1.Maximum observed concentration (Cmax) of divarasib measured using plasma concentration of divarasib collected over 5 days on period 1 and 2 ; 1.2. Area under the concentration‐time curve extrapolated to infinity (AUC 0‐8) of divarasib measured using plasma concentration of divarasib collected over 5 days on period 1 and 2; 1.3. Area under the concentration‐time curve from hour 0 to last measurable concentration (AUC 0‐t) of divarasib measured using plasma concentration of divarasib collected over 5 days on period 1 and 2 SECONDARY OUTCOME: 1. Number of participants with adverse events (AEs) graded as per national cancer institute common terminology criteria for adverse events version 5.0 (NCI CTCAE; v5.0) from signing of informed consent up to Day 28 of Period 2 (approximately 5 weeks) INCLUSION CRITERIA: 1. Males or females of non‐childbearing potential 2. Body mass inde X(BMI) ranges from 18.0 to 32.0 kilogram per meter square (kg/m^2) 3. In good health, determined by no clinically significant findings from medical history, physical examination, triplicate 12‐lead electro cardiogram (ECGs), and vital signs 4. Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check‐in (Day ‐1 of Period 1) (does include alcohol) 5. Negative hepatitis panel (hepatitis B surface antigen, hepatitis B virus core antibody, and hepatitis C virus antibody) and negative Human Immunodeficiency Virus (HIV) antibody screens 6. Able to comply with the study protocol, including an overnight (at least 8 hours) fast before dosing
Epistemonikos ID: 2b91192f022f503ce0ac4bde891ec93e13e25987
First added on: Mar 29, 2024