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

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ClinicalTrials.gov Identifier: NCT03792971
Recruitment Status : Not yet recruiting
First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Galera Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Dextromethorphan HBr Drug: GC4419 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1, Open-label, One-arm, Fixed-sequence Study to Evaluate the Effects of 90 mg Intravenous Infusions of GC4419 on the Single Dose Pharmacokinetics of Dextromethorphan in Healthy Adult Subjects
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fixed Sequence Drug: Dextromethorphan HBr
A single 60 mg dose of DM capsules liquid-filled on Day 1 and Day 3

Drug: GC4419
Daily 90 mg IV infusions over 60 minutes on Day 3 and Day 4




Primary Outcome Measures :
  1. Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): AUC0-t [ Time Frame: 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 ]
  2. Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): AUC0-inf [ Time Frame: 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 ]
  3. Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): Cmax [ Time Frame: 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792971


Contacts
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Contact: Melissa Brookes 610-725-1500 mbrookes@galeratx.com

Sponsors and Collaborators
Galera Therapeutics, Inc.

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Responsible Party: Galera Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03792971     History of Changes
Other Study ID Numbers: GTI-4419-005
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dextromethorphan
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs