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

NCT ID: NCT03792971

Last Updated: 2019-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-10
• Study Completion Date: 2019-02-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fixed Sequence

Group Type: EXPERIMENTAL

Dextromethorphan HBr

Intervention Type: DRUG

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

GC4419

Intervention Type: DRUG

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

Interventions

Dextromethorphan HBr

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

Intervention Type: DRUG

GC4419

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Healthy as defined by:

1. the absence of clinically significant illness and surgery within 4 weeks prior to dosing.

2. the absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.

3. 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:

4. 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:

5. 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.

6. Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.

7. Capable of consent.

8. Consent to perform genotyping for CYP2D6.

Exclusion Criteria

1. Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results

2. Positive urine drug screen or urine cotinine test at screening.

3. History of allergic reactions to GC4419, DM, or other related drugs.

4. Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first DM administration.

5. Poor CYP2D6 metabolizers as determined by genetic testing.

6. Positive pregnancy test at screening.

7. Any reason which, in the opinion of the Principal Investigator, would prevent the subject from participating in the study.

8. Clinically significant ECG abnormalities or vital sign abnormalities

9. History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit

10. History of significant drug abuse

11. 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.

12. Use of medication other than hormonal contraceptives and topical products without significant systemic absorption:

13. Donation of plasma within 7 days prior to dosing.

14. Breast-feeding subject.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galera Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Inventiv Health Clinical - Research Pharmacy Unit

Miami, Florida, United States

Countries

United States

Other Identifiers

GTI-4419-005

Identifier Type: -

Identifier Source: org_study_id