Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06027437
Other study ID # CV028-1012
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 5, 2023
Est. completion date November 10, 2023

Study information

Verified date November 2023
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the relative biological availability and the effect of food on the drug levels of Danicamtiv in health adults.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date November 10, 2023
Est. primary completion date November 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 inclusive - Participants with resting heart rate = 55 bpm - Seasonal allergies that do not require medication at the time of the study are acceptable Exclusion Criteria: - Any acute or chronic medical illness - Head injury, intracranial tumor, or aneurysm within 2 years prior to screening - History of chronic gastrointestinal disorders or gastrointestinal (GI) surgery (including cholecystectomy) that could impact on drug and food absorption and/or drug excretion

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Danicamtiv
Specified dose on specified days.

Locations

Country Name City State
United States Anaheim Clinical Trials Anaheim California

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum observed plasma concentration (Cmax) Up to day 16
Primary Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC(INF)) Up to day 16
Primary Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) Up to day 16
Secondary Time of maximum observed plasma concentration (Tmax) Up to day 16
Secondary Terminal elimination half-life (T-HALF) Up to day 16
Secondary Apparent total body clearance (CLT/F) Up to day 16
Secondary Apparent volume of distribution (Vz/F) Up to day 16
Secondary Number of participants with Adverse Events (AEs) Up to day 43
Secondary Number of participants with Serious Adverse Events (SAEs) Up to day 43
Secondary Number of participants with vital sign abnormalities Up to day 16
Secondary Number of participants with Electrocardiogram (ECG) abnormalities Up to day 16
Secondary Number of participants with Physical Examination (PE) abnormalities Up to day 16
Secondary Number of participants with clinical laboratory abnormalities Up to day 16
See also
  Status Clinical Trial Phase
Completed NCT05029518 - 3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability Phase 1
Completed NCT05001152 - Taste Assessment of Ozanimod Phase 1
Completed NCT04493255 - A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants Phase 1
Completed NCT03457649 - IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers Phase 1
Completed NCT00995891 - Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
Completed NCT05043766 - Evaluation of Oral PF614 Relative to OxyContin Phase 1
Completed NCT05050318 - Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively Phase 4
Completed NCT04466748 - A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects Phase 1
Completed NCT00746733 - Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC Phase 1
Recruiting NCT05929651 - Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy Phase 4
Completed NCT05954039 - Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect N/A
Completed NCT05045716 - A Study of Subcutaneous Lecanemab in Healthy Participants Phase 1
Active, not recruiting NCT02747927 - Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children Phase 3
Completed NCT05533801 - A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants Phase 1
Not yet recruiting NCT03931369 - Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST) Phase 2
Completed NCT03279146 - A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects Phase 1
Recruiting NCT05619874 - Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity N/A
Completed NCT05553418 - Investigational On-body Injector Clinical Study N/A
Completed NCT04092712 - Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers Phase 1
Not yet recruiting NCT06236009 - A First-In-Human Study of TAK-004 in Healthy Adults Phase 1