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NCT06128954

PHASE1

Study Comparing Once Daily Dose of 900mg of TETA 4HCL Against Cuprior® (450mg Trientine Base, Twice Daily).

Sponsor: Orphalan

View on ClinicalTrials.gov

Summary

A randomised, open-label study evaluating the pharmacokinetics, safety, and tolerability of a new once daily dose of 900mg of TETA 4HCL by comparing it against the current marketed Cuprior® formulation (450mg trientine base, twice daily) in healthy male and female participants.

Official title: A Phase I, Single Centre, Randomised, Interventional, Open-Label, Cross-Over Study to Evaluate the Pharmacokinetics (PK) and the Safety and Tolerability of a Total Daily Dose of 900mg of TETA 4HCL, Comparing a New Once Daily TETA 4HCL Formulation (300mg) (3x300mg Trientine Base Tablets, OD) With the Current Marketed Cuprior® Formulation (150mg) (3x150mg Trientine Base Tablets, BD) in Adult Healthy Male and Female Participants

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-01-16

Completion Date

2024-02-16

Last Updated

2026-08-26

Healthy Volunteers

Yes

Conditions

Wilson's Disease

Interventions

DRUG

900mg TETA 4HCl Once Daily Formulation

3x300mg trientine base tablets as a single AM dose

DRUG

900mg TETA 4HCl Cuprior®

6 x150mg trientine base tablets in two equally divided doses

Inclusion Criteria: * Age: 18 to 40 years * Body weight: ≥ 50 kg * BMI: 18.0 to 25.0 kg/m2 * Health: Generally healthy, with no clinically significant illnesses or surgeries in the past 12 weeks * Willingness to comply with trial procedures and restrictions Exclusion Criteria: * Significant current or recurrent disease * Acute significant disease or illness within 7 days before the start of the trial * Clinically significant deviations in blood tests * An estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73m2 * Positive test for alcohol, drugs of abuse, hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) * Pregnant or breastfeeding women * History or regular use of tobacco or other nicotine-containing products within 6 months before the start of the trial * Treatment with an investigational drug within 90 days or 5 half-lives (whichever is longer) or exposure to more than 3 investigational drugs within 12 months of first study drug administration * Use of prescription medication (excluding female hormonal contraception or hormone replacement therapy)within 30 days or 5 half * lives (whichever is longer) prior to first study drug administration, or use of over-the-counter (OTC) medication (including multivitamin, herbal, or homeopathic preparations; Paracetamol use ≤2g per day is permitted) during the 14 days or 5 half-lives of the drug (whichever is longer) before first study drug administration * History of sensitivity/allergy to the study medications or components thereof (mannitol, colloidal anhydrous silica, glycerol dibehenate or magnesium-stearate) * Donation or loss of 450 mL or more of blood or plasma within 16 weeks prior to first trial medication administration or intention to donate blood in the 16 weeks after completing the trial * An inability to follow a standardised diet and meal schedule or inability to fast, as required during the trial * Participants deemed to have difficult veins for cannulation/blood draws

Locations (1)

Richmond Pharmacology Ltd

London, United Kingdom