A Drug-Drug Interaction Study to Evaluate the Effect of Itraconazole on the Pharmacokinetic Profile of Etrumadenant in Healthy Adult Participants

NCT05154136 | Completed Phase 1 FDA Drug

• 1 other identifier: ARC-18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effect of multiple oral doses of itraconazole, on the pharmacokinetics of etrumadenant when etrumadenant is administered as a single dose in healthy adult participants.

Conditions

Healthy Participants

Keywords

Etrumadenant; Itraconazole; Healthy participants; Pharmacokinetics; Drug-Drug Interaction; AB928

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax) of Etrumadenant Administered With or Without Itraconazole

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2

• Area Under the Plasma Concentration-time Curve From 0 to Last Observed Non-zero Concentration [AUC(0-t)] of Etrumadenant Administered With or Without Itraconazole

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2

• Area Under the Plasma Concentration Time Curve From Time '0' Extrapolated to Infinity [AUC(0-inf)] of Etrumadenant Administered With or Without Itraconazole

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2

Secondary Outcomes (16)

• Percentage of AUC(0-inf) Extrapolation (AUC%extrap) of Etrumadenant Administered With or Without Itraconazole

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2

• Apparent Total Plasma Clearance (CL/F) of Etrumadenant Administered With or Without Itraconazole

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2

• Time to Cmax (Tmax) of Etrumadenant Administered With or Without Itraconazole

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2

• Apparent First-order Terminal Elimination Rate Constant (Kel) of Etrumadenant Administered With or Without Itraconazole

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2

• Apparent First Order Terminal Elimination Half-life (t1/2) of Etrumadenant Administered With or Without Itraconazole

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2

Study Arms (1)

Etrumadenant then Etrumadenant + Itraconazole

EXPERIMENTAL

Participants will receive the Treatment A (etrumadenant) followed by Treatment B (etrumadenant + itraconazole). A washout period of 5 days will be maintained between the two treatments.

Drug: Etrumadenant; Drug: Itraconazole

Interventions

Etrumadenant DRUG

Capsule

Also known as: AB928

Etrumadenant then Etrumadenant + Itraconazole

Itraconazole DRUG

Capsule

Etrumadenant then Etrumadenant + Itraconazole

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, adult, male or female (of non-childbearing potential), at the screening visit
• Body mass index between 18 and 32 kilograms/m\^2 inclusive, at screening
• Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG
• Clinical laboratory test results clinically acceptable at screening and check-in
• Non-smokers or ex-smokers (must have ceased smoking and stopped using nicotine containing products \>3 months prior to the first dosing) based on participant self-reporting

You may not qualify if:

• Participants who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, rheumatological, endocrine, connective tissue diseases or disorders
• Have a clinically relevant surgical history in the opinion of the principal investigator or designee
• Have a history of relevant atopy or hypersensitivity to the study drugs or related compounds (e.g., allergy to itraconazole or other azole antifungals
• History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
• Note: This is not an exhaustive list of criterias.

Sponsors & Collaborators

• Arcus Biosciences, Inc.: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Medical Director

  Arcus Biosciences, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study consists of 2 periods with participants sequentially receiving Treatment A (etrumadenant) in Period 1, followed by Treatment B (etrumadenant + itraconazole) in Period 2.

Study Record Dates

• First Submitted: October 16, 2021
• First Posted: December 10, 2021
• Study Start: October 20, 2021
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

US (1)