A single-dose, open label, randomized, three-way cross-over study in healthy volunteers to characterize the pharmacokinetics of the 300 mg trientine capsule and to assess the effect of dissolution rate and the effect of food on the pharmacokinetics of trientine.

A single-dose, open label, randomized, three-way cross-over study in healthy volunteers to characterize the pharmacokinetics of the 300 mg trientine capsule and to assess the effect of dissolution rate and the effect of food on the pharmacokinetics of trientine. - 180194-CS0298 Univar

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46237

Enrollment

Registered

2018-06-11

Start date

2018-07-11

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

hepatolenticular degeneration Wilson's disease

Interventions

Trientine dihydrochloride 300 mg capsule.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male or female subjects;Females must not be pregnant or breastfeeding and must be postmenopausal or agree to use an acceptable form of birth control;Aged 18 to 75 years inclusive at screening.;For more inclusion criteria a reference is made to the protocol.

Exclusion criteria

Exclusion criteria: Has smoked more than 5 cigarettes or equivalents tobacco products per day within 14 days prior to the first dose of study medication.;History or presence of drug or alcohol abuse within the past 5 years. ;For more exclusion criteria a reference is made to the protocol.

Design outcomes

Primary

Measure	Time frame
PK: Cmax, AUC0-t, AUC0-*, Tmax, t1/2 and Kel for trientine.	—

Secondary

Measure	Time frame
PK: Cmax, AUC0-t, AUC0-*, Tmax, t1/2 and Kel for MAT and DAT PD (for treatments A and C only): urinary copper excretion, serum copper and ceruloplasmin Safety: AEs (clinical relevant changes in VS, ECGs and laboratory parameters should be reported as AEs)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)