Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy Participants

Safety and Tolerability Clinical Trial

Official title:

A Blinded, Randomized, Placebo-controlled, Multiple Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ESK-001 Tablets Administered Over 14days to Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05431634
• Other study ID #: ESK-001-003
• Status: Completed
• Phase: Phase 1
• Start date: May 12, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: Alumis Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multiple Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ESK-001 in Healthy Participants

Description:

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Participant is a man or woman between the ages of 18 and 60years, inclusive, at the Screening Visit

• Participant is healthy as determined by medical history, physical examination, vital signs, and routine laboratory parameters

• Other inclusions as specified in the protocol

Exclusion Criteria:

• Participant has a prior exposure to ESK-001

• Participant has a history of hypersensitivity to any of the ingredients of ESK-001

• Other exclusions as specified in the protocol

Related Conditions & MeSH terms

• Safety and Tolerability

Intervention

Drug:
• Experimental drug: ESK-001
Multiple doses of ESK-001

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Alumis Central site	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Alumis Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)	Safety and tolerability	Up to 14 days
Primary	Incidence of Serious Adverse Events (SAEs)	Safety and tolerability	Up to 14 days
Secondary	The area under plasma concentration-time curve from time zero extrapolated to last measurable concentration (AUCt) for ESK001 on Day 1 and Day 14	Pharmacokinetics	Up to 14 days
Secondary	The area under the plasma concentration-curve over the dosing interval (AUC(0-t)) for ESK001 on Day1 and Day 14	Pharmacokinetics	Up to 14 days
Secondary	The observed maximum plasma concentration (Cmax) for ESK001 on Day 1 and Day 14.	Pharmacokinetics	Up to 14 days
Secondary	The time to reach the observed maximum plasma concentration (tmax) for ESK001 on Day 1 and Day 14.	Pharmacokinetics	Up to 14 days
Secondary	Apparent plasma elimination half-life (t½?z) for ESK001 on Day 1 and Day 14	Pharmacokinetics	Up to 14 days
Secondary	Apparent clearance CL(Clearance)/F for ESK001 on Day 1	Pharmacokinetics	Up to 14 days
Secondary	The accumulation ratio for AUC(0-t) (RAC AUC(0-t)) for ESK001 on Day 14	Pharmacokinetics	Up to 14 days
Secondary	The accumulation ratio for Cmax (RAC Cmax) for ESK001 on Day 14.	Pharmacokinetics	Up to 14 days
Secondary	Cytokine induction of pSTAT expression and downstream cytokine production as a measure of tyk2 pathway inhibition by ESK001	Pharmacodynamics	14 days after first dose