A phase 1, open-label, randomized, 2-way crossover study to assess the effects of acid reducing agent(s) on the pharmacokinetics of a single oral dose of JNJ-64417184 in healthy adult participants

A phase 1, open-label, randomized, 2-way crossover study to assess the effects of acid reducing agent(s) on the pharmacokinetics of a single oral dose of JNJ-64417184 in healthy adult participants - Drug-drug Interaction of Multiple-dose JNJ-64417184

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50152

Enrollment

Registered

2020-04-28

Start date

2020-07-21

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory syncytial virus

Interventions

This study will consist of up to 3 periods. The volunteer will receive a different treatment in each period. The 3 treatments are: - Treatment A: a single 400 mg dose of JNJ-64417184 on Day 1 - Tre

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, 18 to 54 years of age, extremes included, at screening. 2. Must have a body mass index between 18.0 and 30.0 kg/m2, extremes included, and body weight not less than 50.0 kg at screening. 3. Healthy on the basis of physical examination, medical and surgical history, and vital signs performed at screening. If there are abnormalities other than those listed in Exclusion Criteria 2 and 3, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator. 4. Must have a normal 12-lead ECG (triplicate) at screening, including: normal sinus rhythm (heart rate between 45 and 100 beats per minute, extremes included); QT interval corrected for heart rate (QTc) according to Fridericia (QTcF)

Exclusion criteria

Exclusion criteria: 1. History of liver or renal dysfunction (calculated creatinine clearance/estimated glomerular filtration rate (eGFR)

Design outcomes

Primary

Measure	Time frame
- To evaluate the effect of multiple-dose administration of lansoprazole on the single-dose PK of JNJ-64417184 in healthy adult participants - To evaluate the effect of time-separated, multiple-dose administration of famotidine on the single-dose PK of JNJ-64417184 in healthy adult participants (optional).	—

Secondary

Measure	Time frame
- To explore the safety and tolerability of single-dose JNJ-64417184 when administered alone and in combination with multiple-dose lansoprazole or famotidine (optional) in healthy adult participants.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)