Pharmacokinetic Evaluation of MDZ028 (MIDAZOLAM)

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Midazolam

Treatments: Drug: Midazolam

Study type: Observational

Funder types: Other

Identifiers

NCT03639428

PI10-PR-DUPONT

Details and patient eligibility

About

Plasma concentration data were collected from 37 paedriatic patients and 12 healthy adults recruited in a single dose, open-label phase II pharmacokinetic study and in a single dose, randomised, open-label two-peiod crossover bioavailability study, respectively. Data were analysed using non-linear mixed effect modeling.

Full description

In the absence of a licensed formulation in many countries worldwide, ADV6209, an innovative 2mg/ml oral solution of midazolam containing cyclodextrin, has been developed for moderate sedation in paediatric patients. Population pharmacokinetics for ADV6209 is reported.

Plasma concentration data were collected from 37 paedriatic patients and 12 healthy adults recruited in a single dose, open-label phase II pharmacokinetic study and in a single dose, randomised, open-label two-peiod crossover bioavailability study, respectively. Data were analysed using non-linear mixed effect modeling. Plasma concentrations of midazolam were discribed by a two-compartement model. An additional one-compartement model was added for a α-hydroxymidazolam.

Enrollment: 37 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Child (boy or girl) for whom surgery under general anesthesia is scheduled.
• Child aged 6 months to 17 years old.
• Child with a body mass index between the 3rd and 97th percentile.
• Child with ASA (American Society of Anesthesiology) status of I or II. Young girl of childbearing age (ie after puberty) and sexually active to have a result negative to the pregnancy test.
• Child whose parents / legal representative (s) agree to sign a consent form.
• Child whose opinion / agreement was / tried to be collected.
• Child and parents / legal representative (s) being ready and able to participate in the study, understanding and undertaking to respect the study procedures throughout the duration of the study.
• Child enrolled in a social security scheme.

Exclusion criteria

• Child with midazolam allergy, benzodiazepine hypersensitivity or hypersensitivity known to one of the excipients of the formulation of the study.
• Child with respiratory disease (severe respiratory failure, acute respiratory depression).
• Child with heart disease.
• Child with gastrointestinal disorders that may affect absorption or gastroesophageal reflux.
• Child with growth disorders or abnormal weight-of-weight.
• Child taking Cytochrome P450 Interactions Within 60 Days of Inclusion in the study.
• Child with kidney failure, liver failure, history of myasthenia gravis, or neurological disease.
• Pregnant or lactating girl.
• Child who has a known human immunodeficiency virus (HIV) infection, or active hepatitis B, or active hepatitis C.
• A child who could present any condition that may prevent his participation in the study, according to the judgment of the investigator.

Trial design

37 participants in 3 patient groups

6 - 23 months

Description:

8 infants between 6 and 23 months received a single 0.3mg/kg midazolam dose of ADV6209

Treatment:

Drug: Midazolam

2-11 years

Description:

17 children between 2 and 11 years received a single 0.3mg/kg midazolam dose of ADV6209

Treatment:

Drug: Midazolam

12-17 years

Description:

12 adolescents between 12 and 17 years received a single 0.3mg/kg midazolam dose of ADV6209

Treatment:

Drug: Midazolam