Evidence map›Paper›PMID 42669735›Full record

ArticleClinical pharmacokinetics2026

A First-in-Human Study of Ulacamten, a Novel Cardiac Myosin Inhibitor for HFpEF.

Justin D Lutz, Neha Maharao, Tyrell Simkins, Kathleen Cheplo, Genzhou Liu, Camelia Dumitrescu, Adrienne Griffith, Rajaa Sukhun, Stephen B Heitner, Stuart Kupfer and 1 more

Registry-linked trialAbstract read
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In one paragraph

Article in Clinical pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05877053 (A Phase 1, Double-blind, Randomized, Placebo-controlled, Multi-part, Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants), which is not on this map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05877053 phase1completednot on this map

A Phase 1, Double-blind, Randomized, Placebo-controlled, Multi-part, Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants

TypeinterventionalSponsorCytokineticsRan2023 to 2024Enrolled102ConditionsHealthy ParticipantsArmsCK-4021586, Placebo for CK-4021586
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Justin D LutzDepartment of Clinical Pharmacology, Cytokinetics, Incorporated, South San Francisco, CA, USA.ORCID http://orcid.org/0009-0009-9353-9139
Neha MaharaoDepartment of Clinical Pharmacology, Cytokinetics, Incorporated, South San Francisco, CA, USA. nmaharao@cytokinetics.com.ORCID http://orcid.org/0000-0001-7512-1737
Tyrell SimkinsDepartment of Clinical Research, Cytokinetics, Incorporated, South San Francisco, CA, USA.
Kathleen CheploDepartment of Clinical Operations, Cytokinetics, Incorporated, South San Francisco, CA, USA.
Genzhou LiuDepartment of Biostatistics, Cytokinetics, Incorporated, South San Francisco, CA, USA.
Camelia DumitrescuDepartment of Drug Safety and Pharmacovigilance, Cytokinetics, Incorporated, South San Francisco, CA, USA.
Adrienne GriffithDepartment of Clinical Pharmacology, Cytokinetics, Incorporated, South San Francisco, CA, USA.
Rajaa SukhunDepartment of Drug Metabolism and Pharmacokinetics, Cytokinetics, Incorporated, South San Francisco, CA, USA.
Stephen B HeitnerDepartment of Clinical Research, Cytokinetics, Incorporated, South San Francisco, CA, USA.
Stuart KupferDepartment of Clinical Research, Cytokinetics, Incorporated, South San Francisco, CA, USA.
Polina GermanDepartment of Clinical Pharmacology, Cytokinetics, Incorporated, South San Francisco, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesUlacamten (CK-4021586) is a small molecule allosteric inhibitor of cardiac myosin in development for treating heart failure with preserved ejection fraction. This first-in-human study evaluated safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and food effect (FE) of ulacamten in healthy adult participants.

methodsThis was a phase I, double-blind, randomized, placebo-controlled, single and multiple ascending dose escalation (SAD, MAD) and FE study. Seven SAD cohorts (n = 10; eight active, two placebo) received oral doses of 10-600 mg, two MAD cohorts received 100 and 200 mg once daily for 7 days, and one FE cohort received a single 150-mg dose. Participants were required to have left ventricular ejection fraction (LVEF) ≥ 60% or ≥ 65% at screening. Intensive PK plasma sampling was conducted (Days 1, 7 [MAD only] for 168 h post dose). Safety was monitored throughout the study. Multiple echocardiographic measurements were collected (for 24 h post dose) for PD assessment.

resultsUlacamten was steadily absorbed, with median plasma half-life of 14-18 h, median t

conclusionsUlacamten demonstrated dose-proportional exposure, a predictable PK/PD relationship with respect to LVEF, and good tolerability, supporting its further clinical development. CLINICAL

trial registrationClinicalTrials.gov identifier: NCT05877053, registered May 23, 2023.

Identifiers

PMID42669735

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