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Influence of Fedratinib on the Pharmacokinetics of the Transporter Probe Substrates Digoxin, Rosuvastatin, and Metformin

NCT04231435 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-05-21

No results posted yet for this study

Summary

This is a nonrandomized, fixed-sequence, open-label study to evaluate the effect of a single dose of fedratinib on the PK, safety, and tolerability of single doses of digoxin, rosuvastatin, and metformin in healthy subjects. The subjects will participate as follows:

* Screening phase
* Treatment phase (includes baseline)
* Follow-up telephone call Subjects will be screened for eligibility during the screening phase. Subjects who meet all inclusion criteria and none of the exclusion criteria will return to the clinical site on Day -1 for protocol-specified assessments, and will be domiciled at the clinical site from Day -1 through the morning of Day 22.

During the study, blood samples will be collected at prespecified times for PK and PD. Urine samples will be collected at prespecified times for urinary PK evaluation of metformin. Subject safety will be monitored throughout the study.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Fedratinib

Oral

DRUG

Digoxin

Oral

DRUG

Rosuvastatin

Oral

DRUG

Metformin

Oral

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

  • Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation

    collaborator INDUSTRY

Principal Investigators

  • Leon Carayannopolous, M.D. · Celgene

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-18
Primary Completion
2020-02-19
Completion
2020-02-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04231435 on ClinicalTrials.gov