Trial Outcomes & Findings for 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 (NCT NCT06391177)
NCT ID: NCT06391177
Last Updated: 2025-03-25
Results Overview
AUC from time 0 to 24 hours post-dose, calculated as: the sum of the product of the concentration of the interval and the width of the interval.
COMPLETED
PHASE1
15 participants
Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
2025-03-25
Participant Flow
A total of 15 participants were enrolled in the United States between May 2024 and September 2024.
Participants were administered vonoprazan once daily (QD) or twice daily (BID).
Participant milestones
| Measure |
Vonoprazan 20 mg QD
Participants were administered vonoprazan 20 mg QD for 4 consecutive days (Days 1 through 4).
|
Vonoprazan 20 mg BID
Participants were administered vonoprazan 20 mg BID for 4 consecutive days (Days 1 through 4).
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
10
|
|
Overall Study
COMPLETED
|
5
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Vonoprazan 20 mg QD
n=5 Participants
Participants were administered vonoprazan 20 mg QD for 4 consecutive days (Days 1 through 4).
|
Vonoprazan 20 mg BID
n=10 Participants
Participants were administered vonoprazan 20 mg BID for 4 consecutive days (Days 1 through 4).
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.4 years
STANDARD_DEVIATION 4.45 • n=5 Participants
|
29.7 years
STANDARD_DEVIATION 3.71 • n=7 Participants
|
31.3 years
STANDARD_DEVIATION 4.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).Population: PK population: included all participants who received sufficient doses of vonoprazan and had sufficient concentration data in milk to support accurate estimation of at least 1 PK parameter in milk.
AUC from time 0 to 24 hours post-dose, calculated as: the sum of the product of the concentration of the interval and the width of the interval.
Outcome measures
| Measure |
Vonoprazan 20 mg QD
n=5 Participants
Participants were administered vonoprazan 20 mg QD for 4 consecutive days (Days 1 through 4).
|
Vonoprazan 20 mg BID
n=10 Participants
Participants were administered vonoprazan 20 mg BID for 4 consecutive days (Days 1 through 4).
|
|---|---|---|
|
Area Under Drug Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) Following the Morning Dose of Vonoprazan in Breast Milk
|
179 ng•h/mL
Standard Deviation 61.3
|
317 ng•h/mL
Standard Deviation 107
|
PRIMARY outcome
Timeframe: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).Population: PK population: included all participants who received sufficient doses of vonoprazan and had sufficient concentration data in milk to support accurate estimation of at least 1 PK parameter in milk.
Maximum observed concentration after dosing.
Outcome measures
| Measure |
Vonoprazan 20 mg QD
n=5 Participants
Participants were administered vonoprazan 20 mg QD for 4 consecutive days (Days 1 through 4).
|
Vonoprazan 20 mg BID
n=10 Participants
Participants were administered vonoprazan 20 mg BID for 4 consecutive days (Days 1 through 4).
|
|---|---|---|
|
Maximum Drug Concentration (Cmax) of Vonoprazan in Breast Milk
|
20.9 ng/mL
Standard Deviation 6.02
|
24.7 ng/mL
Standard Deviation 9.77
|
PRIMARY outcome
Timeframe: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).Population: PK population: included all participants who received sufficient doses of vonoprazan and had sufficient concentration data in milk to support accurate estimation of at least 1 PK parameter in milk.
Minimum observed concentration after dosing.
Outcome measures
| Measure |
Vonoprazan 20 mg QD
n=5 Participants
Participants were administered vonoprazan 20 mg QD for 4 consecutive days (Days 1 through 4).
|
Vonoprazan 20 mg BID
n=10 Participants
Participants were administered vonoprazan 20 mg BID for 4 consecutive days (Days 1 through 4).
|
|---|---|---|
|
Minimum Drug Concentration (Cmin) of Vonoprazan in Breast Milk
|
1.82 ng/mL
Standard Deviation 0.833
|
6.78 ng/mL
Standard Deviation 2.19
|
PRIMARY outcome
Timeframe: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).Population: PK population: included all participants who received sufficient doses of vonoprazan and had sufficient concentration data in milk to support accurate estimation of at least 1 PK parameter in milk.
Average concentration, calculated as: AUC0-24/tau (tau=the difference between the end time of the last interval and dosing time).
Outcome measures
| Measure |
Vonoprazan 20 mg QD
n=5 Participants
Participants were administered vonoprazan 20 mg QD for 4 consecutive days (Days 1 through 4).
|
Vonoprazan 20 mg BID
n=10 Participants
Participants were administered vonoprazan 20 mg BID for 4 consecutive days (Days 1 through 4).
|
|---|---|---|
|
Average Drug Concentration (Cavg) of Vonoprazan in Breast Milk
|
7.55 ng/mL
Standard Deviation 2.58
|
13.3 ng/mL
Standard Deviation 4.51
|
PRIMARY outcome
Timeframe: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).Population: PK population: included all participants who received sufficient doses of vonoprazan and had sufficient concentration data in milk to support accurate estimation of at least 1 PK parameter in milk.
Time to maximum observed concentration (actual midpoint of the interval in which Cmax was observed).
Outcome measures
| Measure |
Vonoprazan 20 mg QD
n=5 Participants
Participants were administered vonoprazan 20 mg QD for 4 consecutive days (Days 1 through 4).
|
Vonoprazan 20 mg BID
n=10 Participants
Participants were administered vonoprazan 20 mg BID for 4 consecutive days (Days 1 through 4).
|
|---|---|---|
|
Time to Cmax (Tmax) of Vonoprazan in Breast Milk
|
1.88 hours
Interval 1.83 to 1.93
|
1.91 hours
Interval 1.88 to 14.8
|
SECONDARY outcome
Timeframe: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).Population: PK population: included all participants who received sufficient doses of vonoprazan and had sufficient concentration data in milk to support accurate estimation of at least 1 PK parameter in milk.
Total amount of drug excreted in breast milk over 24 hours; calculated as the sum of drug concentration × expressed milk volume in each collection interval over 24-hour period.
Outcome measures
| Measure |
Vonoprazan 20 mg QD
n=5 Participants
Participants were administered vonoprazan 20 mg QD for 4 consecutive days (Days 1 through 4).
|
Vonoprazan 20 mg BID
n=10 Participants
Participants were administered vonoprazan 20 mg BID for 4 consecutive days (Days 1 through 4).
|
|---|---|---|
|
Total Amount of Vonoprazan Excreted in Breast Milk
|
0.00241 mg
Standard Deviation 0.00118
|
0.00904 mg
Standard Deviation 0.00530
|
SECONDARY outcome
Timeframe: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).Population: PK population: included all participants who received sufficient doses of vonoprazan and had sufficient concentration data in milk to support accurate estimation of at least 1 PK parameter in milk.
Total amount of drug excreted over 24 hours relative to total dose administered; calculated as the sum of (total amount of drug excreted in each collection interval / total dose received over 24-hour period) \* 100.
Outcome measures
| Measure |
Vonoprazan 20 mg QD
n=5 Participants
Participants were administered vonoprazan 20 mg QD for 4 consecutive days (Days 1 through 4).
|
Vonoprazan 20 mg BID
n=10 Participants
Participants were administered vonoprazan 20 mg BID for 4 consecutive days (Days 1 through 4).
|
|---|---|---|
|
Percentage of Vonoprazan Excreted in Breast Milk Relative to the Total Dose Received
|
0.0120 percentage of vonoprazan
Standard Deviation 0.00592
|
0.0226 percentage of vonoprazan
Standard Deviation 0.0132
|
SECONDARY outcome
Timeframe: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).Population: PK population: included all participants who received sufficient doses of vonoprazan and had sufficient concentration data in milk to support accurate estimation of at least 1 PK parameter in milk.
Estimated weight adjusted daily dose consumed by the infant through breast milk; calculated as total amount of drug excreted over 24-hour period / weight of infant. Calculation used the nominal infant weight of 6.0 kg which is the approximate 50th percentile for a 3-month old infant.
Outcome measures
| Measure |
Vonoprazan 20 mg QD
n=5 Participants
Participants were administered vonoprazan 20 mg QD for 4 consecutive days (Days 1 through 4).
|
Vonoprazan 20 mg BID
n=10 Participants
Participants were administered vonoprazan 20 mg BID for 4 consecutive days (Days 1 through 4).
|
|---|---|---|
|
Estimated Infant Daily Dose of Vonoprazan
|
0.000401 mg/kg/day
Standard Deviation 0.000197
|
0.00151 mg/kg/day
Standard Deviation 0.000883
|
SECONDARY outcome
Timeframe: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).Population: PK population: included all participants who received sufficient doses of vonoprazan and had sufficient concentration data in milk to support accurate estimation of at least 1 PK parameter in milk.
Percentage of daily infant dose relative to the daily maternal dose; calculated as (daily infant dose / daily maternal dose) \* 100.
Outcome measures
| Measure |
Vonoprazan 20 mg QD
n=5 Participants
Participants were administered vonoprazan 20 mg QD for 4 consecutive days (Days 1 through 4).
|
Vonoprazan 20 mg BID
n=10 Participants
Participants were administered vonoprazan 20 mg BID for 4 consecutive days (Days 1 through 4).
|
|---|---|---|
|
Estimated Relative Infant Dose to the Total Maternal Dose Received of Vonoprazan
|
0.128 percentage of total maternal dose
Standard Deviation 0.0556
|
0.269 percentage of total maternal dose
Standard Deviation 0.186
|
Adverse Events
Vonoprazan 20 mg QD
Vonoprazan 20 mg BID
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vonoprazan 20 mg QD
n=5 participants at risk
Participants were administered vonoprazan 20 mg QD for 4 consecutive days (Days 1 through 4).
|
Vonoprazan 20 mg BID
n=10 participants at risk
Participants were administered vonoprazan 20 mg BID for 4 consecutive days (Days 1 through 4).
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Day 1 up to Day 11
A treatment emergent adverse event (TEAE) was defined as any event that occurred after the first dose of the study drug or any event at Baseline that worsened in either intensity or frequency after the first dose of the study drug until 30 days after the last dose of the study drug. Safety population: included all participants who received at least 1 dose of study drug.
|
20.0%
2/10 • Day 1 up to Day 11
A treatment emergent adverse event (TEAE) was defined as any event that occurred after the first dose of the study drug or any event at Baseline that worsened in either intensity or frequency after the first dose of the study drug until 30 days after the last dose of the study drug. Safety population: included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/5 • Day 1 up to Day 11
A treatment emergent adverse event (TEAE) was defined as any event that occurred after the first dose of the study drug or any event at Baseline that worsened in either intensity or frequency after the first dose of the study drug until 30 days after the last dose of the study drug. Safety population: included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Day 1 up to Day 11
A treatment emergent adverse event (TEAE) was defined as any event that occurred after the first dose of the study drug or any event at Baseline that worsened in either intensity or frequency after the first dose of the study drug until 30 days after the last dose of the study drug. Safety population: included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • Day 1 up to Day 11
A treatment emergent adverse event (TEAE) was defined as any event that occurred after the first dose of the study drug or any event at Baseline that worsened in either intensity or frequency after the first dose of the study drug until 30 days after the last dose of the study drug. Safety population: included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Day 1 up to Day 11
A treatment emergent adverse event (TEAE) was defined as any event that occurred after the first dose of the study drug or any event at Baseline that worsened in either intensity or frequency after the first dose of the study drug until 30 days after the last dose of the study drug. Safety population: included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Day 1 up to Day 11
A treatment emergent adverse event (TEAE) was defined as any event that occurred after the first dose of the study drug or any event at Baseline that worsened in either intensity or frequency after the first dose of the study drug until 30 days after the last dose of the study drug. Safety population: included all participants who received at least 1 dose of study drug.
|
20.0%
2/10 • Day 1 up to Day 11
A treatment emergent adverse event (TEAE) was defined as any event that occurred after the first dose of the study drug or any event at Baseline that worsened in either intensity or frequency after the first dose of the study drug until 30 days after the last dose of the study drug. Safety population: included all participants who received at least 1 dose of study drug.
|
Additional Information
Phathom Medical Information
Phathom Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Principal investigators (PIs) are not permitted to publish the data. Data may be considered for reporting at a scientific meeting or for publication in a scientific journal. In these cases, the sponsor will be responsible for these activities and will work with the PIs to determine how the manuscript is written and edited, the number and order of authors, the publication to which it will be submitted, and any other related issues. The sponsor has final approval authority over all such issues.
- Publication restrictions are in place
Restriction type: OTHER