Pharmacokinetic Evaluation of MDZ028

NCT03639428 | Completed

• 1 other identifier: PI10-PR-DUPONT
• Study Type: observational
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Midazolam

Keywords

pharmacokinetics; child; cyclodextrin; moderate sedation

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic analysis of the oral solution of midazolam (ADV6209)

  The Aim of the study was to assess the pharmacokinetic analysis of an oral solution of midazolam (ADV6209) oral formulation in paedriatic patients from 6 months to 18 years ols in order to support dosing recommendations. All subjects received a single 0.3mg/kg midazolam dose of ADV6209, without exceeding a total dose of 10 mg.Population pharmacokinetic modelling was performed to characterise the concentration-time course of midazolam and its main active metabolite, and to evaluate the changes in clearance and volume of distibution in the different age groups.

  1 day

Study Arms (3)

6 - 23 months

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

Drug: Midazolam

2-11 years

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

Drug: Midazolam

12-17 years

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

Drug: Midazolam

Interventions

Midazolam DRUG

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

Also known as: midazolam dose of ADV6209

12-17 years; 2-11 years; 6 - 23 months

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The planned enrollment is 36 children, stratified in two groups: 24 children between 6 months and 11 years, and 12 children between 12 and 17 years. Age is considered in years past by the date of inclusion. Children aged between 6 months and 11 years old should be homogenous in both age groups 6-23 months and 2-11 years. For example, at least 4 children in the 6-23 month age group will be recruited. Children likely to be included will be hospitalized in the pediatric surgery department at Amiens University Hospital. Children who will be included in this study will not be able to participate in another study within 3 months of their inclusion in this study.

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hervé Dupont, MD, PhD

  CHU AMIENS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 21, 2018
• Study Start: June 23, 2011
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share