Pharmacokinetic Evaluation of MDZ028

NCT ID: NCT03639428

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-06-23
• Study Completion Date: 2017-11-30

Brief Summary

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.

Detailed 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.

Conditions

Midazolam

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

6 - 23 months

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

Midazolam

Intervention Type: DRUG

All subjects received a sigle 0.3mg/kg midazolam dose os ADV6209

2-11 years

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

Midazolam

Intervention Type: DRUG

All subjects received a sigle 0.3mg/kg midazolam dose os ADV6209

12-17 years

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

Midazolam

Intervention Type: DRUG

All subjects received a sigle 0.3mg/kg midazolam dose os ADV6209

Interventions

Midazolam

All subjects received a sigle 0.3mg/kg midazolam dose os ADV6209

Intervention Type: DRUG

Other Intervention Names

midazolam dose of ADV6209

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hervé Dupont, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU AMIENS

Other Identifiers

PI10-PR-DUPONT

Identifier Type: -

Identifier Source: org_study_id