A Study to Investigate the Absorption, Metabolism, Excretion, and Mass Balance of GC4419 in Healthy Adult Subjects

NCT03163173 | Completed Phase 1 FDA Drug

• 1 other identifier: GTI-4419-001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

GC4419 is being studied to treat and prevent oral mucositis (painful inflammation) in cancer patients who receive radiation and chemotherapy. In this study, GC4419 will be mixed with a small amount of radioactive material in order to find out how much study drug is in the blood and to see how the drug is processed and eliminated from the body. The safety and how subjects tolerate the study drug will also be studied.

Conditions

Healthy Volunteers; Healthy

Keywords

Healthy Adult; Superoxide Dismutase; Absorption; Metabolism; Elimination; Mass Balance; Male Subjects

Outcome Measures

Primary Outcomes (6)

• Mass balance of GC4419

  Total radioactivity found in biological specimens

  From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]

• Total radioactivity in plasma (AUC0-t)

  The area under the concentration time or concentration equivalent time curve, from time 0 to the last observed non-zero concentration (Ct)

  From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]

• Major metabolites in biological specimens.

  Total concentrations of GC4419 and its metabolites found in biological specimens

  From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]

• 14C radioactivity in whole blood

  Change over time in percentage of 14C radioactivity in whole blood

  From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]

• Total radioactivity in plasma (Cmax)

  Maximum observed concentration or concentration equivalent

  From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]

• Total radioactivity in plasma (Tmax)

  Time to reach Cmax

  From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]

Study Arms (1)

Single Arm - Treatment Group

EXPERIMENTAL

30 mg (\~100 μCi) dose of \[14C\]GC4419 administered as an IV infusion over 15 minutes on Day 1 following an overnight fast

Drug: GC4419

Interventions

GC4419 DRUG

30 mg (\~100 μCi) dose of \[14C\]GC4419

Single Arm - Treatment Group

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, adult, male, 19-55 years of age, inclusive, at screening.
• Continuous non-smoker who has not used nicotine containing products for at least 3 months prior to dosing and throughout the study.
• Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
• No clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs
• A non-vasectomized subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond dosing.
• Must agree not to donate sperm from dosing until 90 days after dosing.
• Be willing and able to comply with the protocol.

You may not qualify if:

• Subject is mentally or legally incapacitated
• History or presence of clinically significant medical or psychiatric condition or disease
• History or presence of alcoholism or drug abuse within the past 2 years prior to dosing.
• History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
• Regularly has less than 1 bowel movement every 2 days.
• Recent history (within 2 weeks of Day 1) of abnormal bowel habits
• Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
• Blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg
• Heart rate is lower than 40 bpm or higher than 99 bpm
• Unable to refrain from or anticipates the use of any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing and throughout the study.
• Has been on a diet incompatible with the on study diet
• Donation of blood or significant blood loss within 56 days prior to dosing.
• Plasma donation within 7 days prior to dosing.
• Has received radiolabeled substances or has been exposed to radiation sources over the past 12 months or is likely to receive radiation exposure or radioisotopes within the next 12 months such that participation in this study would increase their total exposure beyond the recommended levels considered safe
• Participation in another clinical study within 28 days prior to dosing.

Sponsors & Collaborators

• Galera Therapeutics, Inc.: lead
• Celerion: collaborator

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

avasopasem manganese

Study Officials

• Jon T Holmlund, MD

  Galera Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 22, 2017
• Study Start: August 14, 2017
• Primary Completion: October 13, 2017
• Study Completion: October 13, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)