---
title: Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics
nct_id: NCT01318265
overall_status: COMPLETED
phase: PHASE1
sponsor: Bayer
study_type: INTERVENTIONAL
primary_condition: Pharmacokinetics
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01318265.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01318265"
ct_last_update_post_date: 2014-11-03
last_seen_at: "2026-05-12T07:18:05.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics

**Official Title:** A Phase I, Non-Randomized, Open Label Study to Determine the Effetc of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of Regorafenib (BAY73-4506) in Healthy Volunteers

**NCT ID:** [NCT01318265](https://clinicaltrials.gov/study/NCT01318265)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** Bayer
- **Conditions:** Pharmacokinetics
- **Start Date:** 2011-03
- **Completion Date:** 2011-07
- **CT.gov Last Update:** 2014-11-03

## Brief Summary

The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** MALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Healthy male subjects between 18 and 45 years of age, inclusive
* BMI between 18 and 32 kg/m2 inclusive

Exclusion Criteria:

* Subjects with evidence of disease, conditions affecting drug absorption or metabolism
* Treatment with other investigational drug within 30 days
* History of regular alcohol or recreational drug consumption
* Use of prescription drugs within 14 days
* Use of nonprescription drugs and dietary supplement within 7 days
* Blood donation within 30 days
```

## Arms

- **Arm1** (EXPERIMENTAL)

## Interventions

- **Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole** (DRUG) — Treatment 1: A single 160 mg dose of BAY73-4506. Treatment 2: Ketoconazole 400 mg once daily from Day -4 to Day 3. A single 160 mg dose of BAY73-4506 on Day 1.

## Primary Outcomes

- **Area under the plasma concentration versus time curve from zero to infinity ( Plasma AUCinf) of BAY73-4506 given alone or with ketoconazole.** _(time frame: 1 month)_
- **Peak plasma concentration (Cmax) of BAY73-4506 given alone or with ketoconazole** _(time frame: 1 month)_

## Secondary Outcomes

- **Plasma AUCinf of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.** _(time frame: 1 month)_
- **Plasma Cmax of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.** _(time frame: 1 month)_
- **Number of subjects with adverse events following a single oral dose of BAY73-4506, adminstered alone and concomitantly with ketoconazole.** _(time frame: 1 month)_

## Locations (1)

- Brighton, Massachusetts, 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.|brighton|massachusetts|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01318265.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01318265*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*