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

NCT06575595 | Completed Phase 1 FDA Drug

• 2 other identifiers: 7240-010MK-7240-010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Area Under the Curve from Time 0 to Infinity (AUC0-inf): Treatment A

  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

  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

  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

  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

  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

  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

  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 Outcomes (7)

• AUC0-inf: Treatment B vs Treatment C

  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

  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

  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

  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

  Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)

Study Arms (3)

Treatment A

EXPERIMENTAL

Single dose delivered subcutaneously (SC) with an autoinjector

Biological: Tulisokibart

Treatment B

EXPERIMENTAL

Single dose of concentration A delivered SC with syringe and vial

Biological: Tulisokibart

Treatment C

EXPERIMENTAL

Single dose of concentration B delivered SC with syringe and vial

Biological: Tulisokibart

Interventions

Tulisokibart BIOLOGICAL

single dose via SC autoinjector (Treatment A) or concentration A or concentration B SC injection via syringe and vial (Treatments B and C)

Also known as: MK-7240

Treatment A; Treatment B; Treatment C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

QPS Missouri ( Site 0003)

Springfield, Missouri, 65802, United States

Location

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 28, 2024
• Study Start: September 24, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)