Roniciclib Mass Balance Study

A Phase I, Single Center, Open-label, Non-randomized, Non-placebo-controlled Study to Investigate the Metabolism, Excretion Pattern, Mass Balance, Safety, Tolerability and Pharmacokinetics of Orally Administered [14C]-Roniciclib (BAY 1000394) in Patients With Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02390154

Enrollment

Registered

2015-03-17

Start date

2015-04-30

Completion date

2016-06-30

Last updated

2016-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Brief summary

The purpose of this trial is to investigate the fate of the roniciclib (study drug) in the body in a so called mass-balance study. This means to investigate how the study drug is absorbed, distributed, broken down (metabolized) and removed (excreted or eliminated) from the body.

Interventions

DRUGroniciclib (BAY 1000394)

Single dose , 2.5 mg roniciclib spiked with 5.0 MBq of \[14C\] roniciclib solution

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* \- Male or female subjects aged ≥18 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 * Subjects with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable * Adequate bone marrow, liver, and renal functions as assessed by laboratory requirements to be conducted within 14 days prior to the first dose of study drug:

Exclusion criteria

* Previous deep vein thrombosis (within the last 6 months), arterial thrombotic events (including strokes), or pulmonary embolism * History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class III or IV, angina (within past 6 months prior to study entry), myocardial infarction, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) * Anticancer chemotherapy or immunotherapy within 4 weeks of study entry. Mitomycin C or nitrosoureas should not be given within 6 weeks of study entry. Accepted exemptions are bisphosphonates, luteinising hormone releasing hormone (LHRH) agonists for prostate cancer, and mitotane for adrenal carcinoma. * Radiotherapy within 3 weeks prior to the first dose of study drug. Palliative radiotherapy will be allowed * Intake of strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil (withdrawn in the US), nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin and voriconazole) and strong CYP3A4 inducers (e.g., carbamazepine, phenytoin , rifampin and St. John's Wort)

Design outcomes

Primary

Measure	Time frame
Amount of Roniciclib in urine as percentage of the dose of total radioactivity.	Up to 336 hours
Amount of Roniciclib in feces as percentage of the dose of total radioactivity.	Up to 336 hours
Amount of Roniciclib in vomit as percentage of the dose of total radioactivity	Up to 336 hours
Cmaxof roniciclib in plasma	up to 336 hours
AUC(0-tlast) of roniciclib in plasma	up to 336 hours
AUC of roniciclib in plasma	up to 336 hours
Cmax of total radioactivity in whole blood and plasma	up to 336 hours
AUC(0-tlast) of total radioactivity in whole blood and plasma	Up to 336 hours
AUC of total radioactivity in whole blood and plasma	up to 336 hours

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026