---
title: A Drug-Drug Interaction Study to Evaluate the Effect of Itraconazole on the Pharmacokinetic Profile of Etrumadenant in Healthy Adult Participants
nct_id: NCT05154136
overall_status: COMPLETED
phase: PHASE1
sponsor: Arcus Biosciences, Inc.
study_type: INTERVENTIONAL
primary_condition: Healthy Participants
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05154136.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05154136"
ct_last_update_post_date: 2024-05-24
last_seen_at: "2026-05-12T07:21:01.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Drug-Drug Interaction Study to Evaluate the Effect of Itraconazole on the Pharmacokinetic Profile of Etrumadenant in Healthy Adult Participants

**Official Title:** A Phase 1, Open-Label, 2-period Drug-Drug Interaction Study to Investigate the Effect of Multiple Doses of Itraconazole on the Single-Dose Pharmacokinetic Profile of AB928 in Healthy Adult Participants

**NCT ID:** [NCT05154136](https://clinicaltrials.gov/study/NCT05154136)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Arcus Biosciences, Inc.
- **Conditions:** Healthy Participants
- **Start Date:** 2021-10-20
- **Completion Date:** 2021-12-10
- **CT.gov Last Update:** 2024-05-24

## 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.

## Eligibility

- **Minimum age:** 19 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
```

## Arms

- **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.

## Interventions

- **Etrumadenant** (DRUG) — Capsule
- **Itraconazole** (DRUG) — Capsule

## Primary Outcomes

- **Maximum Observed Plasma Concentration (Cmax) of Etrumadenant Administered With or Without Itraconazole** _(time frame: 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** _(time frame: 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** _(time frame: 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

- **Percentage of AUC(0-inf) Extrapolation (AUC%extrap) of Etrumadenant Administered With or Without Itraconazole** _(time frame: 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** _(time frame: 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** _(time frame: 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** _(time frame: 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** _(time frame: 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 Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Etrumadenant Administered With or Without Itraconazole** _(time frame: 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)_
- **Cmax of Etrumadenant Metabolites When Etrumadenant is Administered With or Without Itraconazole** _(time frame: 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)_
- **AUC(0-t) of Etrumadenant Metabolites When Etrumadenant is Administered With or Without Itraconazole** _(time frame: 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)_
- **AUC(0-inf) of Etrumadenant Metabolites When Etrumadenant is Administered With or Without Itraconazole** _(time frame: 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)_
- **AUC%extrap of Etrumadenant Metabolites When Etrumadenant is Administered With or Without Itraconazole** _(time frame: 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)_
- **CL/F of Etrumadenant Metabolites When Etrumadenant is Administered With or Without Itraconazole** _(time frame: 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)_
- **Tmax of Etrumadenant Metabolites When Etrumadenant is Administered With or Without Itraconazole** _(time frame: 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)_
- **Kel of Etrumadenant Metabolites When Etrumadenant is Administered With or Without Itraconazole** _(time frame: 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)_
- **t1/2 of Etrumadenant Metabolites When Etrumadenant is Administered With or Without Itraconazole** _(time frame: 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)_
- **Vz/F of Etrumadenant Metabolites When Etrumadenant is Administered With or Without Itraconazole** _(time frame: 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)_
- **Number of Participants with Treatment Emergent Adverse Events** _(time frame: Up to 30 days)_

## Locations (1)

- Celerion, Lincoln, Nebraska, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.celerion|lincoln|nebraska|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05154136.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05154136*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*