Pharmacokinetic (PK) Characterization of Subcutaneous Tulisokibart (MK-7240-010)

February 14, 2025 updated by: Merck Sharp & Dohme LLC

A Pharmacokinetic Study of Tulisokibart Administered Subcutaneously Via Autoinjector or Syringe in Healthy Adult Participants

The primary objectives of the study are to characterize the pharmacokinetics (PK) of a single subcutaneous (SC) dose of tulisokibart (MK-7240) administered via autoinjector (AI) (Treatment A) and to characterize the PK of different concentrations of tulisokibart following SC administration of a single dose via vial/syringe (Treatments B and C). There is no formal hypothesis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Springfield, Missouri, United States, 65802
        • QPS Missouri ( Site 0003)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Is in good health
  • Has a body mass index (BMI) between 18 and 32 kg/m2, inclusive
  • Has a weight between 50 and 100 kg, inclusive

Exclusion Criteria:

  • Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
  • Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years
  • Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years or has had diagnostic evaluation suggestive of malignancy (eg, chest or breast imaging) in which the possibility of malignancy cannot be reasonably excluded following additional clinical assessments
  • Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or nonprescription drugs or food
  • Has a positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV); OR positive hepatitis B core antibody (HBcAb) with negative hepatitis B core antibody (HBsAb)
  • Has a history of more than one episode of herpes zoster infection or history of disseminated herpes zoster infection
  • Has a history of or current active tuberculosis (TB) infection; history of latent TB that was not fully treated or a positive QuantiFERON-TB test at screening
  • Is a smoker and/or has used nicotine or nicotine-containing products (eg, nicotine patch and electronic cigarette) within 3 months of screening
  • Consumes greater than 3 servings of alcoholic beverages per day
  • Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A
Single dose delivered subcutaneously (SC) with an autoinjector
Biological: Tulisokibart
single dose via SC autoinjector (Treatment A) or concentration A or concentration B SC injection via syringe and vial (Treatments B and C)
Other Names:
  • MK-7240
Experimental: Treatment B
Single dose of concentration A delivered SC with syringe and vial
Biological: Tulisokibart
single dose via SC autoinjector (Treatment A) or concentration A or concentration B SC injection via syringe and vial (Treatments B and C)
Other Names:
  • MK-7240
Experimental: Treatment C
Single dose of concentration B delivered SC with syringe and vial
Biological: Tulisokibart
single dose via SC autoinjector (Treatment A) or concentration A or concentration B SC injection via syringe and vial (Treatments B and C)
Other Names:
  • MK-7240

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve from Time 0 to Infinity (AUC0-inf): Treatment A
Time Frame: Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Blood will be collected at pre-specified time points to determine the AUC0-inf of tulisokibart. AUC0-inf is defined as the area under concentration-time curve of tulisokibart from time zero to infinity.
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Area Under the Curve from Time 0 to Last Measurable Concentration (AUC0- last): Treatment A
Time Frame: Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Blood will be collected at pre-specified time points to determine the AUC0-last of tulisokibart. AUC0-last is defined as the area under the concentration-time curve from time zero to time of last measurable concentration of tulisokibart.
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Maximum Plasma Concentration (Cmax): Treatment A
Time Frame: Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Blood will be collected at pre-specified time points to determine the Cmax of tulisokibart. Cmax is defined as the maximum concentration of tulisokibart reached.
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Time to Cmax (Tmax): Treatment A
Time Frame: Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Blood will be collected at pre-specified time points to determine the Tmax of tulisokibart. Tmax is defined as the time to maximum concentration of tulisokibart reached.
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Clearance after Nonintravenous Administration (CL/F): Treatment A
Time Frame: Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Blood will be collected at pre-specified time points to determine the CL/V of tulisokibart. CL/F is the rate at which the tulisokibart is completely removed from plasma.
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Volume of Distribution (V/F): Treatment A
Time Frame: Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Blood will be collected at pre-specified time points to determine the V/F of tulisokibart. V/F is the volume of distribution of tulisokibart.
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Half Life (t1/2): Treatment A
Time Frame: Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Blood will be collected at pre-specified time points to determine the t1/2 of tulisokibart. t1/2 is defined as the time required to divide plasma concentration of tulisokibart by half.
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-inf: Treatment B vs Treatment C
Time Frame: Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Blood will be collected at pre-specified time points to determine the AUC0-inf of tulisokibart. AUC0-inf is defined as the area under concentration-time curve of tulisokibart from time zero to infinity.
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
AUC0-last: Treatment B vs Treatment C
Time Frame: Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Blood will be collected at pre-specified time points to determine the AUC0-last of tulisokibart. AUC0-last is defined as the area under the concentration-time curve from time zero to time of last measurable concentration of tulisokibart.
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Cmax: Treatment B vs Treatment C
Time Frame: Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Blood will be collected at pre-specified time points to determine the Cmax of tulisokibart. Cmax is defined as the maximum concentration of tulisokibart reached.
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Tmax: Treatment B vs Treatment C
Time Frame: Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Blood will be collected at pre-specified time points to determine the Tmax of tulisokibart. Tmax is defined as the time to maximum concentration of tulisokibart reached.
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
CL/V: Treatment B vs Treatment C
Time Frame: Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Blood will be collected at pre-specified time points to determine the CL/V of tulisokibart. CL/F is the rate at which the tulisokibart is completely removed from plasma.
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
V/F: Treatment B vs Treatment C
Time Frame: Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Blood will be collected at pre-specified time points to determine the V/F of tulisokibart. V/F is the volume of distribution of tulisokibart.
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
t1/2: Treatment B vs Treatment C
Time Frame: Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)
Blood will be collected at pre-specified time points to determine the t1/2 of tulisokibart. t1/2 is defined as the time required to divide plasma concentration of tulisokibart by half.
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2024

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7240-010
  • MK-7240-010 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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