Study to Evaluate the Effects of 90 mg Intravenous Infusions of GC4419 on the Single Dose Pharmacokinetics of Dextromethorphan in Healthy Adult Subjects

NCT03792971 | Completed Phase 1 FDA Drug

• 1 other identifier: GTI-4419-005
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a single center, phase 1, open-label, fixed-sequence study under fasting conditions to evaluate the effect of 90 mg intravenous (IV) infusions of GC4419 on the single-dose pharmacokinetic (PK) of dextromethorphan (DM) capsules liquid filled.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): AUC0-t

  Pre-dose on Day 1, and at 0.5, 1 (immediately prior to the end of GC4419 infusion), 2, 3, 4, 6, 8, 12, and 24 hours after the start of infusion

• Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): AUC0-inf

  Pre-dose on Day 1, and at 0.5, 1 (immediately prior to the end of GC4419 infusion), 2, 3, 4, 6, 8, 12, and 24 hours after the start of infusion

• Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): Cmax

  Pre-dose on Day 1, and at 0.5, 1 (immediately prior to the end of GC4419 infusion), 2, 3, 4, 6, 8, 12, and 24 hours after the start of infusion

Study Arms (1)

Fixed Sequence

EXPERIMENTAL

Drug: Dextromethorphan HBr; Drug: GC4419

Interventions

Dextromethorphan HBr DRUG

A single 60 mg dose of DM capsules liquid-filled on Day 1 and Day 3

Fixed Sequence

GC4419 DRUG

Daily 90 mg IV infusions over 60 minutes on Day 3 and Day 4

Fixed Sequence

Eligibility Criteria

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

You may qualify if:

• Male or female, non-smoker, ≥ 18 and ≤ 55 years of age, with BMI \> 18.5 and \< 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
• Healthy as defined by:
• the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
• the absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
• Females of childbearing potential must be willing to use acceptable contraceptive method throughout the study and for 30 days after the last study drug administration:
• Male subjects must be willing to use acceptable contraceptive method from the first dosing until at least 90 days after the last study drug administration:
• Male subjects (including men who have had vasectomies) with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after the last study drug administration.
• Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
• Capable of consent.
• Consent to perform genotyping for CYP2D6.

You may not qualify if:

• Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results
• Positive urine drug screen or urine cotinine test at screening.
• History of allergic reactions to GC4419, DM, or other related drugs.
• Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first DM administration.
• Poor CYP2D6 metabolizers as determined by genetic testing.
• Positive pregnancy test at screening.
• Any reason which, in the opinion of the Principal Investigator, would prevent the subject from participating in the study.
• Clinically significant ECG abnormalities or vital sign abnormalities
• History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit
• History of significant drug abuse
• Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
• Use of medication other than hormonal contraceptives and topical products without significant systemic absorption:
• Donation of plasma within 7 days prior to dosing.
• Breast-feeding subject.

Sponsors & Collaborators

• Galera Therapeutics, Inc.: lead

Study Sites (1)

Inventiv Health Clinical - Research Pharmacy Unit

Miami, Florida, 33136, United States

Location

MeSH Terms

Interventions

Dextromethorphan; avasopasem manganese

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

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: December 21, 2018
• First Posted: January 4, 2019
• Study Start: February 10, 2019
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: June 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)