A Study of Sotatercept (MK-7962) in Healthy Females Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation (MK-7962-027)

NCT06930664
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Phase
Phase 1
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Recruitment status
Completed
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Participants
146
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Lead sponsor
Merck Sharp & Dohme LLC
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Start date
2025-05-16
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Number of sites
4
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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.
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Short title
A Study of Sotatercept (MK-7962) in Healthy Females Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation (MK-7962-027)
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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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2025-11-25
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First posted
2025-04-16
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Registry last updated
2025-12-15
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Primary completion date
2025-11-11
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Start date
2025-05-16
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Actual participants
146
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Participants
146
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
4
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Merck Sharp & Dohme LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06930664
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ClinicalTrials.gov ID
NCT06930664
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Basic science
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. 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)

    Blood samples will be collected to determine the AUC0-inf of sotatercept in plasma.

  2. 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

    Blood samples will be collected to determine the AUC0-last of sotatercept in plasma.

  3. Maximum Observed Concentration (Cmax) of Sotatercept at High Dose

    Timeframe: Predose and at designated timepoints (up to approximately 120 days postdose

    Blood samples will be collected to determine the Cmax of sotatercept in plasma.

  1. Time of the Maximum Observed Concentration (Tmax) of Sotatercept High Dose

    Timeframe: Predose and at designated timepoints (up to approximately 120 days postdose

    Blood samples will be collected to determine the Tmax of sotatercept in plasma.

  2. Apparent Terminal Elimination Half-Life (t1/2) of Sotatercept at High Dose

    Timeframe: Predose and at designated timepoints (up to approximately 120 days postdose

    Blood samples will be collected to determine the t1/2 of sotatercept in plasma.

  3. Apparent Total Plasma Clearance (CL/F) of Sotatercept at High Dose

    Timeframe: Predose and at designated timepoints (up to approximately 120 days postdose

    Blood samples will be collected to determine the CL/F of sotatercept in plasma.

  4. 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

    Blood samples will be collected to determine the Vz/F of sotatercept in plasma.

  5. Cmax of Sotatercept Low Dose

    Timeframe: Predose and at designated timepoints (up to approximately 120 days postdose

    Blood samples will be collected to determine the Cmax of sotatercept in plasma.

  6. Tmax of Sotatercept at Low Dose

    Timeframe: Predose and at designated timepoints (up to approximately 120 days postdose

    Blood samples will be collected to determine the Tmax of sotatercept in plasma.

  7. AUC0-inf of Sotatercept at Low Dose

    Timeframe: Predose and at designated timepoints (up to approximately 120 days postdose

    Blood samples will be collected to determine the AUC0-inf of sotatercept in plasma.

  8. AUC0-last of Sotatercept at Low Dose

    Timeframe: Predose and at designated timepoints (up to approximately 120 days postdose

    Blood samples will be collected to determine the AUC0-last of sotatercept in plasma.

  9. t1/2 of Sotatercept at Low Dose

    Timeframe: Predose and at designated timepoints (up to approximately 120 days postdose

    Blood samples will be collected to determine the t1/2 of sotatercept in plasma.

  10. CL/F of Sotatercept at Low Dose

    Timeframe: Predose and at designated timepoints (up to approximately 120 days postdose

    Blood samples will be collected to determine the CL/F of sotatercept in plasma.

  11. Vz/F of Sotatercept at Low Dose

    Timeframe: Predose and at designated timepoints (up to approximately 120 days postdose

    Blood samples will be collected to determine the Vz/F of sotatercept in plasma.

  12. Number of Participants who Experienced an Adverse Event (AE)

    Timeframe: Up to approximately 120 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.

  13. Number of Participants who Discontinued the Study Due to an AE

    Timeframe: Up to approximately 120 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.

Sources for outcomes
clinicaltrials.gov

Sex
Female
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
85 Years
Healthy volunteers
Yes

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)

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
Sources for eligibility
clinicaltrials.gov

  • Anaheim Clinical Trials ( Site 0007)Anaheim, United States
  • Advanced Pharma CR, LLC ( Site 0005)Miami, United States
  • QPS-MRA, LLC ( Site 0004)South Miami, United States
  • Bio-Kinetic Clinical Applications, LLD dba QPS-MO ( Site 0003)Springfield, United States
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • MK-7962-027
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (1)