A pharmacokinetic study of sodium phenylbutyrate in healthy adults for refractory pediatric cholestatic disease's therapy

A pharmacokinetic study of sodium phenylbutyrate in healthy adults for refractory pediatric cholestatic disease's therapy - A pharmacokinetic study of sodium phenylbutyrate in healthy adults

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027674

Enrollment

Registered

2017-06-07

Start date

2017-06-15

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Adult

Interventions

administer sodium phenylbutylate orally at less than 3.3-4.3g/m2 before meal administer sodium phenylbutylate orally at less than 3.3-4.3g/m2 after meal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Healthy adults (subjects more than 20 years old who have not experienced any serious diseases) 2) Those who can visit our institutions. 3) Those who don't need any medication at present. 4) Those who can intake medicine orally. 5) Those who can receive the observation essential for this study. 6) Those who have been determined eligible by principal investigator or sub-investigator from physical and clinical examinations. 7) Those who have agreed with participating in this study by written informed consent prior to the study.

Exclusion criteria

Exclusion criteria: 1) Those who have hypersensitivity with phenylbutylate, its metabolites, drug additives and/or benzoate, etc. 2) Those who have experienced serious disease. 3) Those who have received medication in the previous two months. 4) Those who have received more than 200ml whole blood sampling in the previous 4 weeks, or blood component sampling in the previous 2 weeks. 5) Those who have received more than 400ml whole blood sampling in the previous 12 weeks. 6) Those who have been included in any phase 1 clinical trial for medicine containing new active ingredient in the previous 4 months. 7) Those who are less than 20 years old. 8) Drug addicts. 9) Alcoholics 10) Those who have been determined ineligible by principal investigator or sub-investigator.

Design outcomes

Primary

Measure	Time frame
To determine concentration of phenylbutylate and its metabolites in blood and urine after oral administration of sodium phenylbutyrate	—

Secondary

Measure	Time frame
1) Plasma amino acid fraction (isoleucine, glutamine, glutamic acid, argineine), and anmonia 2) Adverse events	—

Countries

Japan

Contacts

Public ContactKei Minowa

Juntendo University, Faculty of Medicine Department of Pediatrics

kminowa@juntendo.ac.jp03-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

A pharmacokinetic study of sodium phenylbutyrate in healthy adults for refractory pediatric cholestatic disease&#39;s therapy