HealthyPhase 1NCT04019574
Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy Subjects
A Phase 1 study testing CR845 0.5 mcg/kg IV, CR845 3 mcg/kg IV and Moxifloxacin 400 mg Oral Tablet in people with Healthy, run by Cara Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 1, randomized, double-blind (except for moxifloxacin), placebo- and positive-controlled, single-site, 4-way crossover study to investigate the effects of single therapeutic and supratherapeutic IV doses of difelikefalin (CR845) on the QTc interval in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CR845 0.5 mcg/kg IV, CR845 3 mcg/kg IV and Moxifloxacin 400 mg Oral Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2019to 29 Oct 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight between 50 to 120 kg and body mass index within 18 to 29 kg/m2 at Screening;
- Current nonsmokers who have not used any tobacco- or nicotine-containing products (chewed or smoked) or replacement products, including, but not limited to, electronic cigarettes, in the 45 days prior to Screening.
Who cannot join
- Past or present diseases, which as judged by the Investigator, may affect the outcome of this study;
- Any condition or situation that, in the opinion of the Investigator, would prevent proper evaluation of the safety or efficacy of the study treatment according to the study protocol;
- History of hypersensitivity or allergy to moxifloxacin or any other study treatment or history of tendonitis or tendon rupture with moxifloxacin or any other quinolone type drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo- and Positive-Controlled, Four-way Crossover Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy Subjects
This is a Phase 1, randomized, double-blind (except for moxifloxacin), placebo- and positive-controlled, single-site, 4-way crossover study to investigate the effects of single therapeutic and supratherapeutic IV doses of difelikefalin (CR845) on the QTc interval in healthy adult subjects. Subjects will be randomized to a treatment sequence consisting of 4 treatment periods with a minimum 5-day washout between treatments. Subjects will receive each of the study treatments over the course of the study. Randomized subjects will receive the assigned study treatment as a single dose in the fasted state in the morning on Day 1 of each treatment period.
- Conditions
- Healthy
- Being tested
- CR845 0.5 mcg/kg IV, CR845 3 mcg/kg IV, Moxifloxacin 400 mg Oral Tablet, Placebo
- Keywords
- Difelikefalin, CR845, QTc, TQT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CR845 0.5 mcg/kg IVDrug
Also called Difelikefalin 0.5 mcg/kg
0.5 mcg/kg IV CR845
CR845 3 mcg/kg IVDrug
Also called Difelikefalin 3 mcg/kg
3 mcg/kg IV CR845
Moxifloxacin 400 mg Oral TabletDrug
Also called Avelox
400 mg Oral Moxifloxacin
PlaceboOther
IV Placebo as a bolus injection
| Study group | Role | What they receive |
|---|---|---|
| CR845 0.5 mcg/kg IV (Therapeutic Dose) | Experimental | Not described Receives: Drug: CR845 0.5 mcg/kg IV |
| CR845 3 mcg/kg IV (Supratherapeutic Dose) | Experimental | Not described Receives: Drug: CR845 3 mcg/kg IV |
| Placebo IV | Placebo comparator | Not described Receives: Other: Placebo |
| Moxifloxacin 400 mg | Active comparator | Not described Receives: Drug: Moxifloxacin 400 mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTc change from baseline following CR845 treatment.
Measured: Baseline, Day 1
Secondary outcomes (2)
Change from baseline in QTc with Bazett correction (QTcB).
Measured: Baseline, Day 1
Change from baseline in Heart Rate.
Measured: Baseline, Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start20 Jun 2019
- Primary completion22 Oct 2019
- Study completion29 Oct 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cara Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frédérique Menzaghi, PhD, Study director, Cara Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019574
- Sponsor's protocol ID
- CR845-100201
- Status last verified
- Feb 2020
- First submitted
- 8 Jul 2019
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- 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 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Positive-Controlled, Four-way Crossover Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04019574
- Acronym / sponsor ID
- CR845-100201
- Conditions
- Healthy
- Keywords
- Difelikefalin, CR845, QTc, TQT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Cara Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 22 Oct 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 15 Jul 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 is a Phase 1, randomized, double-blind (except for moxifloxacin), placebo- and positive-controlled, single-site, 4-way crossover study to investigate the effects of single therapeutic and supratherapeutic IV doses of difelikefalin (CR845) on the QTc interval in healthy adult subjects. Subjects will be randomized to a treatment sequence consisting of 4 treatment periods with a minimum 5-day washout between treatments. Subjects will receive each of the study treatments over the course of the study. Randomized subjects will receive the assigned study treatment as a single dose in the fasted state in the morning on Day 1 of each treatment period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CR845 0.5 mcg/kg IV (Therapeutic Dose) | Experimental | Drug: CR845 0.5 mcg/kg IV |
| CR845 3 mcg/kg IV (Supratherapeutic Dose) | Experimental | Drug: CR845 3 mcg/kg IV |
| Placebo IV | Placebo comparator | Other: Placebo |
| Moxifloxacin 400 mg | Active comparator | Drug: Moxifloxacin 400 mg Oral Tablet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body weight between 50 to 120 kg and body mass index within 18 to 29 kg/m2 at Screening;
- Current nonsmokers who have not used any tobacco- or nicotine-containing products (chewed or smoked) or replacement products, including, but not limited to, electronic cigarettes, in the 45 days prior to Screening.
Key exclusion criteria (3 listed)
- Past or present diseases, which as judged by the Investigator, may affect the outcome of this study;
- Any condition or situation that, in the opinion of the Investigator, would prevent proper evaluation of the safety or efficacy of the study treatment according to the study protocol;
- History of hypersensitivity or allergy to moxifloxacin or any other study treatment or history of tendonitis or tendon rupture with moxifloxacin or any other quinolone type drug.
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 |
|---|---|---|
| CR845 0.5 mcg/kg IVAlso: Difelikefalin 0.5 mcg/kg0.5 mcg/kg IV CR845 | Drug | CR845 0.5 mcg/kg IV (Therapeutic Dose) |
| CR845 3 mcg/kg IVAlso: Difelikefalin 3 mcg/kg3 mcg/kg IV CR845 | Drug | CR845 3 mcg/kg IV (Supratherapeutic Dose) |
| Moxifloxacin 400 mg Oral TabletAlso: Avelox400 mg Oral Moxifloxacin | Drug | Moxifloxacin 400 mg |
| PlaceboIV Placebo as a bolus injection | Other | Placebo IV |
Primary outcome
QTc change from baseline following CR845 treatment.
Time frame: Baseline, Day 1
2 secondary outcomes
Change from baseline in QTc with Bazett correction (QTcB).
Time frame: Baseline, Day 1
Change from baseline in Heart Rate.
Time frame: Baseline, Day 1
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 21 Feb 2020.
- 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.
Frédérique Menzaghi, PhD study director
Cara Therapeutics
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 CR845 0.5 mcg/kg IV, CR845 3 mcg/kg IV and Moxifloxacin 400 mg Oral Tablet in people with Healthy, run by Cara 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 2 inclusion and 3 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 21 Feb 2020. 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. Some participants in this study may receive a placebo. 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?
QTc change from baseline following CR845 treatment. (time frame: Baseline, Day 1). 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 21 Feb 2020.