Clinical trial NCT06930664: A Study of Sotatercept (MK-7962) in Healthy Females Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation (MK-7962-027)
Official title: A Phase 1 Clinical Study in Healthy Females of Nonchildbearing Potential to Compare the Pharmacokinetics of Sotatercept (MK-7962) Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-04-16
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of the study is to learn what happens to different forms of sotatercept medications in a healthy person's body over time. Researchers want to know if there is a difference in the healthy person's body when different forms of sotatercept medications are given.


Eligibility criteria: Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health before randomization
* Has a body weight between 75 and 100 kg, inclusive
* Is assigned female sex at birth and is a participant of nonchildbearing potential (PONCBP) defined as one of the following:

  * Premenarchal
  * Premenopausal with documented hysterectomy and/or bilateral salpingectomy
  * Postmenopausal
  * Medical cause of permanent infertility (eg, Müllerian agenesis, androgen insensitivity)

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of opportunistic infection (eg, invasive candidiasis or pneumocystis pneumonia)
* Has had a serious local infection (eg, cellulitis, abscess) or systemic infection (eg, septicemia) within 3 months prior to screening

Primary outcomes:
measure: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Sotatercept at High Dose
timeFrame: Predose and at designated timepoints (up to approximately 120 days postdose)
measure: Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Sotatercept at High Dose
timeFrame: Predose and at designated timepoints (up to approximately 120 days postdose
measure: Maximum Observed Concentration (Cmax) of Sotatercept at High Dose
timeFrame: Predose and at designated timepoints (up to approximately 120 days postdose
Secondary outcomes:
measure: Time of the Maximum Observed Concentration (Tmax) of Sotatercept High Dose
timeFrame: Predose and at designated timepoints (up to approximately 120 days postdose
measure: Apparent Terminal Elimination Half-Life (t1/2) of Sotatercept at High Dose
timeFrame: Predose and at designated timepoints (up to approximately 120 days postdose
measure: Apparent Total Plasma Clearance (CL/F) of Sotatercept at High Dose
timeFrame: Predose and at designated timepoints (up to approximately 120 days postdose
measure: Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) of Sotatercept at High Dose
timeFrame: Predose and at designated timepoints (up to approximately 120 days postdose
measure: Cmax of Sotatercept Low Dose
timeFrame: Predose and at designated timepoints (up to approximately 120 days postdose
measure: Tmax of Sotatercept at Low Dose
timeFrame: Predose and at designated timepoints (up to approximately 120 days postdose
measure: AUC0-inf of Sotatercept at Low Dose
timeFrame: Predose and at designated timepoints (up to approximately 120 days postdose
measure: AUC0-last of Sotatercept at Low Dose
timeFrame: Predose and at designated timepoints (up to approximately 120 days postdose
measure: t1/2 of Sotatercept at Low Dose
timeFrame: Predose and at designated timepoints (up to approximately 120 days postdose
measure: CL/F of Sotatercept at Low Dose
timeFrame: Predose and at designated timepoints (up to approximately 120 days postdose
measure: Vz/F of Sotatercept at Low Dose
timeFrame: Predose and at designated timepoints (up to approximately 120 days postdose
measure: Number of Participants who Experienced an Adverse Event (AE)
timeFrame: Up to approximately 120 days
measure: Number of Participants who Discontinued the Study Due to an AE
timeFrame: Up to approximately 120 days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials ( Site 0007)
state: California
city: Miami
country: United States
facility: Advanced Pharma CR, LLC ( Site 0005)
state: Florida
city: South Miami
country: United States
facility: QPS-MRA, LLC ( Site 0004)
state: Florida
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, LLD dba QPS-MO ( Site 0003)
state: Missouri
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: