HealthyPhase 1NCT03792971
Study to Evaluate the Effects of 90 mg Intravenous Infusions of GC4419 on the Single Dose Pharmacokinetics of Dextromethorphan in Healthy Adult Subjects
A Phase 1 study testing Dextromethorphan HBr and GC4419 in people with Healthy, run by Galera Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dextromethorphan HBr and GC4419
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2019to 15 Feb 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Inventiv Health Clinical - Research Pharmacy Unit
Miami, Florida, 33136
About this study
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
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
- Being tested
- Dextromethorphan HBr, GC4419
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextromethorphan HBrDrug
A single 60 mg dose of DM capsules liquid-filled on Day 1 and Day 3
GC4419Drug
Daily 90 mg IV infusions over 60 minutes on Day 3 and Day 4
| Study group | Role | What they receive |
|---|---|---|
| Fixed Sequence | Experimental | Not described Receives: Drug: Dextromethorphan HBr; Drug: GC4419 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): AUC0-t
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start10 Feb 2019
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792971
- Sponsor's protocol ID
- GTI-4419-005
- Status last verified
- Jun 2019
- First submitted
- 21 Dec 2018
- Last updated
- 19 Jun 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03792971
- Acronym / sponsor ID
- GTI-4419-005
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Galera Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fixed Sequence | Experimental | Drug: Dextromethorphan HBr, Drug: GC4419 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextromethorphan HBrA single 60 mg dose of DM capsules liquid-filled on Day 1 and Day 3 | Drug | Fixed Sequence |
| GC4419Daily 90 mg IV infusions over 60 minutes on Day 3 and Day 4 | Drug | Fixed Sequence |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dextromethorphan HBr and GC4419 in people with Healthy, run by Galera Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.