What side effects are associated with this type of intervention?

Common side effects for investigational drugs similar to CK-4021586 include mild hypertriglyceridemia, skin rash, gastrointestinal distress, and injection site reactions. Serious adverse events are rare but can include creatine phosphokinase elevation, generalized pain, severe allergic reactions, and capillary leak syndrome. Neurocognitive symptoms have also been reported in a small percentage of cases.

What prior FDA approvals exist?

The FDA has approved various investigational drugs for studies in healthy subjects to assess their safety, tolerability, and pharmacokinetics. These studies are crucial for understanding how a drug behaves in the human body before it is tested in patients with specific conditions. Examples include drugs like GLP-1 receptor agonists, which have been studied for their safety profiles in healthy individuals before being approved for conditions like type 2 diabetes. Such studies help determine appropriate dosing, potential side effects, and the overall safety of new drugs.

What other types of research exist?

Promising, novel alternatives to CK-4021586 for healthy subjects in 2024 could include investigational drugs that are in Phase I clinical trials and are being evaluated for their safety and pharmacokinetics. Examples include BGJ398, a Fibroblast Growth Factor Receptor (FGFR) inhibitor, and other early-phase investigational drugs targeting various molecular pathways. These alternatives are being studied for their safety profiles and pharmacokinetics in healthy individuals, making them potential candidates for further consideration.

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CK-4021586 Safety Study in Healthy Subjects

Phase 1

Recruiting

Research Sponsored by Cytokinetics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy male and female participants aged between 18 and 55 years (inclusive) with a body mass index between 18.0 and 30.0 kg/m2 (inclusive), with a body weight > 50.0 kg

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time frame for sad cohorts: day -1 - day 7; time frame for mad cohorts: day -1 - day 14; time frame for food effect cohorts: days 1 to 7 (treatment periods 1 and 2)

Summary

This trial tests a new drug, CK-4021586, on healthy people to see if it's safe and how it affects the heart and blood absorption.

Who is the study for?

Healthy adults aged 18-55 with a BMI of 18.0-30.0 kg/m2 and weight over 50 kg can join this trial. They shouldn't have any major health issues, allergies to drugs, or history of substance abuse in the last two years. Participants must not have had certain stomach surgeries that affect drug absorption.

What is being tested?

The study is testing CK-4021586's safety after one dose and repeated doses in healthy people. It will also check how much of the drug gets into the blood, its effects on heart function, and if food affects its levels after a single dose.

What are the potential side effects?

Possible side effects are not detailed but monitoring for general safety and tolerability suggests potential for typical drug-related reactions such as headaches, nausea, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18-55 years old, with a BMI of 18-30 and weigh more than 50 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame for sad cohorts: day -1 - day 7; time frame for mad cohorts: day -1 - day 14; time frame for food effect cohorts: days 1 to 7 (treatment periods 1 and 2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame for sad cohorts: day -1 - day 7; time frame for mad cohorts: day -1 - day 14; time frame for food effect cohorts: days 1 to 7 (treatment periods 1 and 2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame for sad cohorts: day -1 - day 7; time frame for mad cohorts: day -1 - day 14; time frame for food effect cohorts: days 1 to 7 (treatment periods 1 and 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and severity of AEs

Secondary study objectives

Changes over time from baseline in echocardiographic parameters including, but not limited to, LVEF

Primary PK parameters of CK-4021586 including AUC

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Food EffectExperimental Treatment1 Intervention

Healthy subjects will be administered CK-4021586 with and without food in a cross-over fashion

Group II: CK-4021586 for SAD CohortExperimental Treatment1 Intervention

Subjects will be assigned to one of 8 planned dose cohorts and receive single doses of CK-4021586

Group III: CK-4021586 for MAD CohortExperimental Treatment1 Intervention

Subjects will be assigned to one of 4 planned dose cohorts and receive multiple doses of CK-4021586

Group IV: Placebo for SAD CohortPlacebo Group1 Intervention

Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo

Group V: Placebo for MAD CohortPlacebo Group1 Intervention

Subjects will be assigned to one of approximately 4 planned cohorts and receive multiple of placebo

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments in healthy subjects often aim to evaluate the safety, tolerability, and pharmacokinetics of new drugs. These treatments typically involve mechanisms that affect cardiovascular function, such as modulation of heart rate, blood pressure, and myocardial contractility. For example, drugs may act on ion channels, adrenergic receptors, or enzymes involved in cardiac muscle contraction. Understanding these mechanisms is crucial for healthy subjects as it helps determine the drug's potential therapeutic benefits and risks, ensuring that any adverse effects are identified early in the drug development process.

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