Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HSY244 in Participants With Atrial Fibrillation (NCT NCT04582409)

Last Updated: 2024-06-20

Results Overview

Conversion to sinus rhythm was monitored using a Holter monitoring device through 90 minutes after the start of study drug administration. If a participant had been monitored for at least 45 minutes and did not convert to sinus rhythm for at least one minute, the primary endpoint was defined as 'no'. If a participant converted to sinus rhythm for at least one minute at any time during the post-treatment 90 minutes observation period, regardless of the length of time monitored, the primary endpoint was to be defined as 'yes'.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

90 minutes from the start of study drug administration

Results posted on

2024-06-20

Participant Flow

A screening period of up to 3 days (72 hours) was used to assess eligibility.

Participant milestones

Participant milestones
Measure	HSY244 HSY244 150 mg concentrate solution for injection via intravenous infusion	Placebo Placebo concentrate solution for injection via intravenous infusion
Overall Study STARTED	7	6
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HSY244 in Participants With Atrial Fibrillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HSY244 n=7 Participants HSY244 150 mg concentrate solution for injection via intravenous infusion	Placebo n=6 Participants Placebo concentrate solution for injection via intravenous infusion	Total n=13 Participants Total of all reporting groups
Age, Continuous	60.6 years STANDARD_DEVIATION 9.73 • n=5 Participants	60.0 years STANDARD_DEVIATION 4.05 • n=7 Participants	60.3 years STANDARD_DEVIATION 7.36 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized White	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90 minutes from the start of study drug administration

Population: Pharmacodynamic (PD) analysis set: Participants with available PD data and no protocol deviations with relevant impact on PD data.

Outcome measures

Outcome measures
Measure	HSY244 n=7 Participants HSY244 150 mg concentrate solution for injection via intravenous infusion	Placebo n=6 Participants Placebo concentrate solution for injection via intravenous infusion
Number of Participants With Conversion to Sinus Rhythm for at Least 1 Minute Within 90 Minutes From the Start of Study Drug Administration.	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 (0 min (pre-dose), 15 min (end of infusion), 30 min , 60 min, 90 min and 180 min) and Day 5

Population: Pharmacokinetic (PK) analysis set: Participants with at least one available valid PK concentration measurement, who received the investigational product and with no protocol deviations that impact on PK data

The Cmax is the maximum (peak) observed plasma drug concentration after single-dose administration. Actual recorded sampling times were taken into consideration for PK calculations.

Outcome measures

Outcome measures
Measure	HSY244 n=7 Participants HSY244 150 mg concentrate solution for injection via intravenous infusion	Placebo Placebo concentrate solution for injection via intravenous infusion
Maximum Observed Plasma Concentration (Cmax)	4800 ng/mL Standard Deviation 3890	—

SECONDARY outcome

Timeframe: Day 1 (0 min (pre-dose), 15 min (end of infusion), 30 min , 60 min, 90 min and 180 min) and Day 5

Tmax is the time to reach maximum (peak) plasma drug concentration after single dose administration (time). Actual recorded sampling times were taken into consideration for PK calculations.

Outcome measures

Outcome measures
Measure	HSY244 n=7 Participants HSY244 150 mg concentrate solution for injection via intravenous infusion	Placebo Placebo concentrate solution for injection via intravenous infusion
Time to Reach the Maximum Concentration After Drug Administration (Tmax)	0.28 Hour Interval 0.25 to 0.3	—

SECONDARY outcome

Timeframe: Day 1 (0 min (pre-dose), 15 min (end of infusion), 30 min , 60 min, 90 min and 180 min) and Day 5

AUClast is the AUC from time zero to the last measurable concentration sampling time (tlast). Actual recorded sampling times were taken into consideration for PK calculations.

Outcome measures

Outcome measures
Measure	HSY244 n=6 Participants HSY244 150 mg concentrate solution for injection via intravenous infusion	Placebo Placebo concentrate solution for injection via intravenous infusion
Area Under the Plasma Concentration-time Curve (AUClast)	2960 h*ng/mL Standard Deviation 1510	—

Adverse Events

HSY244

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Total

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HSY244 n=7 participants at risk HSY244 150 mg concentrate solution for injection via intravenous infusion	Placebo n=6 participants at risk Placebo concentrate solution for injection via intravenous infusion	Total n=13 participants at risk Total
Cardiac disorders Atrial fibrillation	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	7.7% 1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	HSY244 n=7 participants at risk HSY244 150 mg concentrate solution for injection via intravenous infusion	Placebo n=6 participants at risk Placebo concentrate solution for injection via intravenous infusion	Total n=13 participants at risk Total
Cardiac disorders Atrial fibrillation	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	16.7% 1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	15.4% 2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up
Gastrointestinal disorders Flatulence	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	7.7% 1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up
Gastrointestinal disorders Nausea	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	16.7% 1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	7.7% 1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up
General disorders Infusion site pain	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	16.7% 1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	7.7% 1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up
Injury, poisoning and procedural complications Procedural hypertension	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	16.7% 1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	7.7% 1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up
Investigations Blood pressure increased	28.6% 2/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	15.4% 2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up
Investigations Blood urine present	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	7.7% 1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up
Metabolism and nutrition disorders Hypokalaemia	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	16.7% 1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	15.4% 2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	33.3% 2/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	23.1% 3/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up
Musculoskeletal and connective tissue disorders Limb discomfort	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	7.7% 1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up
Musculoskeletal and connective tissue disorders Muscle tightness	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	7.7% 1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	7.7% 1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	7.7% 1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	7.7% 1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up
Nervous system disorders Burning sensation	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	7.7% 1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up
Nervous system disorders Paraesthesia	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	7.7% 1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up
Nervous system disorders Presyncope	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	16.7% 1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	7.7% 1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up
Nervous system disorders Tremor	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	7.7% 1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up
Skin and subcutaneous tissue disorders Dermatitis contact	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up	7.7% 1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days. Any sign or symptom that occurs during the conduct of the trial and safety follow-up