Status:
COMPLETED
Study to Evaluate the Effects of 90 mg Intravenous Infusions of GC4419 on the Single Dose Pharmacokinetics of Dextromethorphan in Healthy Adult Subjects
Lead Sponsor:
Galera Therapeutics, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03792971
Start Date
February 10 2019
End Date
February 15 2019
Last Update
June 19 2019
Active Locations (1)
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1
Inventiv Health Clinical - Research Pharmacy Unit
Miami, Florida, United States, 33136