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CompletedNCT02819271Updated Jan 23, 2017

A First-in-Human Study of the Safety of Single Continuous Intravenous (IV) Infusions of CXL-1427 for up to 48 Hours in Healthy Volunteers

A Phase 1 interventional study of CXL-1427 Ascending Dose and Placebo in Heart Failure, sponsored by Bristol-Myers Squibb. Completed. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-23.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This study is designed to assess a safe dosage of the drug CXL-1427 (BMS-986231) in healthy volunteers.

02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 80 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • No evidence of any acute or chronic health disorder
  • Not have taken any prescription medication within 15 days of study entry
  • Not have taken any over-the-counter medication or herbal/vitamin supplement within 3 days of study entry
  • Not have not have any dietary restrictions
  • Have a body mass index (BMI) of ≥18 to ≤34
  • Weigh at least 50kg (110 pounds)

Exclusion criteria

Exclusion Criteria:

  • Be a current or recent (within 6 months of the Screening Visit) smoker or user of any nicotine-containing product
  • Have a history of symptomatic hypotension, orthostatic hypotension or syncope
  • Have a history of headaches or other symptoms attributable to caffeine withdrawal
  • Have a history of any bleeding diathesis
  • Have a positive serology screen for HIV antibody, hepatitis B surface antigen or hepatitis C antibody at screening

Other protocol defined inclusion/exclusion criteria could apply

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    CXL-1427 (BMS-986231)

    Experimental

    Drug: CXL-1427 Ascending Dose · Drug: CXL-1427 Descending Dose

  • Placebo comparator
    Placebo

    Placebo

    Other: Placebo

Interventions

  • DrugCXL-1427 Ascending Dose

    Also known as: BMS-986231

  • OtherPlacebo
  • DrugCXL-1427 Descending Dose

    Also known as: BMS-986231

06

What researchers measure

Primary outcomes

  1. Safety measured by percentage of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 31 days

  2. Tolerability measured by percentage of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 31 days

Secondary outcomes

  1. Steady-state plasma concentration (Css)

    Time frame: Up to 4 days

  2. Area under the plasma concentration (AUC) vs. time curve

    Time frame: Up to 4 days

  3. Terminal elimination half-life (1/2)

    Time frame: Up to 4 days

  4. Total body clearance (CL)

    Time frame: Up to 4 days

  5. Steady-state volume of distributions (Vss)

    Time frame: Up to 4 days

  6. Time to Css

    Time frame: Up to 4 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02819271
Lead sponsor
Bristol-Myers Squibb
Collaborators
Cardioxyl Pharmaceuticals, Inc
Responsible party
Sponsor
First posted
Jun 30, 2016
Start date
Feb 2014
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Jan 23, 2017

Study contacts

Cardioxyl Pharmaceuticals
study director · Cardioxyl Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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