Comparing different forms of sotatercept in healthy women
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
This study is testing how different forms of sotatercept are processed in the bodies of healthy women to see if one works better than the other.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 3 sites (Anaheim, California and 2 other locations) |
| Trial ID | NCT06930664 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate how different formulations of sotatercept, a medication, are processed in the bodies of healthy females. Participants will receive either a liquid formulation administered via an autoinjector or a lyophilized formulation. The study will monitor and compare the pharmacokinetics of these formulations over time. The goal is to determine if there are significant differences in how these forms affect the body.
Who should consider this trial
Good fit: Ideal candidates are healthy females aged between 75 and 100 kg who are not of childbearing potential.
Not a fit: Patients with a history of opportunistic infections or recent serious infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved formulations of sotatercept that enhance patient outcomes.
How similar studies have performed: While this specific approach is novel, similar studies have shown promise in evaluating different drug formulations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Anaheim, California and 2 other locations
- Anaheim Clinical Trials ( Site 0007) — Anaheim, California, United States (Recruiting)
- Advanced Pharma CR, LLC ( Site 0005) — Miami, Florida, United States (Recruiting)
- QPS-MRA, LLC ( Site 0004) — South Miami, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.