Phase 1
Completed N=44
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vonoprazan and Lansoprazole in Healthy Participants
Healthy Participants
Source: ClinicalTrials.gov NCT04729101 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Gastric pH >4 Holding Time Ratio (HTR): Percentage of Time Gastric pH Was Above 4 Over a 24-hour Monitoring Period Following Study Drug Administration — 62.40; 22.61; 87.81; 42.32 percentage of time
Summary
To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of vonoprazan (20 mg) and lansoprazole (30 mg) following single (Day 1) and multiple doses (Day 7).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gastric pH >4 Holding Time Ratio (HTR): Percentage of Time Gastric pH Was Above 4 Over a 24-hour Monitoring Period Following Study Drug Administration |
62.40; 22.61; 87.81; 42.32 | — |
| PRIMARY Mean Gastric pH Over a 24-hour Monitoring Period Following Study Drug Administration (pH0-24) |
4.606; 2.848; 5.903; 3.783 | — |
| PRIMARY Area Under the Concentration-Time Curve From Time 0 to the 24-Hour Time Point (AUC0-24) |
200.6; 2677 | — |
| PRIMARY Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) |
229.5; 2679 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
21.79; 1110 | — |
| PRIMARY Time to Reach Cmax (Tmax) |
2.005; 1.499 | — |
| PRIMARY Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) at Steady State (ss) |
261.4; 3246 | — |
| PRIMARY Cmax at Steady State (Cmax,ss) |
27.39; 1164 | — |
| PRIMARY Tmax at Steady State (Tmax,ss) |
2.005; 1.510 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must fulfill all the following inclusion criteria to be eligible for participation in the study:
- Healthy, adult, male or female 18 - 55 years of age, inclusive, at screening.
- Continuous nonsmoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study, based on participant self-reporting.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2 at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee.
- Alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT) 460 msec (males) or >470 msec (females) or has electrocardiogram (ECG) findings deemed abnormal with clinical significance by the PI or designee at screening.
- Estimated creatinine clearance 1.22 mg/dL at screening or check-in.
- Unable to refrain from or anticipates the use of:
- Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing and throughout the study. Medication listed as part of acceptable birth control methods will be allowed. After randomization, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the PI or designee. Topical lidocaine may be administered for pH probe insertion. Hormone replacement therapy will also be allowed.
- Any drugs known to be significant inducers of CYP3A4/5, CYP1A2, and/or CYP2C19 for 28 days prior to the first dosing and throughout the study. Appropriate sources will be consulted by the PI or designee to confirm lack of PK / PD interaction with study drug.
- Has been on a diet incompatible with the on-study diet, in the opinion of the PI or designee, within the 30 days prior to the first dosing and throughout the study.
- Donation of blood or significant blood loss within 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
- Participation in another clinical study within 30 days prior to the first dosing. The 30 day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.
Data sourced from ClinicalTrials.gov (NCT04729101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.