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Phase 2a Study to Evaluate Suppression of Methotrexate-induced Mucositis by TK112690

NCT04046250 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-08-25

Study results available
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Summary

Patients will receive methotrexate at a dose of 45 mg/m2 administered weekly for 4 consecutive weeks as an iv infusion along with a nutritional supplement administered two hours before the methotrexate. One hour before the methotrexate treatment the patients will be administered the first infusion of the day of either TK112690 or placebo depending on randomization. Five hours after the methotrexate treatment the patients will be administered the second treatment of either TK112690 or placebo depending on randomization. The TK112690 dose will be 45 mg/kg.

Conditions

Interventions

DRUG

TK-112690

TK112690 treatment pre-methotrexate treatment

DRUG

Placebo TK-112690

Placebo

Sponsors & Collaborators

  • Crystal Life Sciences

    collaborator INDUSTRY

  • Tosk, Inc.

    lead INDUSTRY

Principal Investigators

  • Emile Youssef, MD, PhD · Tosk, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2019-10-10
Completion
2020-03-31
FDA Drug
Yes

Countries

  • India

Study Locations

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Entities

Diseases

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 NCT04046250 on ClinicalTrials.gov