Trials / Completed
CompletedNCT06391177
A Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once Daily or Vonoprazan 20 mg Twice Daily
A Phase 1, Open-label Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once Daily or Vonoprazan 20 mg Twice Daily
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Phathom Pharmaceuticals, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The primary objective is to determine the pharmacokinetics (PK) of vonoprazan in breast milk of healthy lactating women who have received vonoprazan administered once daily or vonoprazan 20 mg administered twice daily for 4 consecutive days.
Conditions
- Erosive Esophagitis
- Heartburn
- Symptomatic Nonerosive Gasroesophageal Reflux Disease
- Helicobacter Pylori Infection
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vonoprazan | Oral tablet. |
Timeline
- Start date
- 2024-05-07
- Primary completion
- 2024-09-13
- Completion
- 2024-09-19
- First posted
- 2024-04-30
- Last updated
- 2025-03-25
- Results posted
- 2025-03-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06391177. Inclusion in this directory is not an endorsement.