A Study to Evaluate the Pharmacokinetics and Safety of Doripenem in Children and Adolescents with Cystic Fibrosis

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2015-001225-16-Outside-EU/EEA
• Date of registration: 24/04/2015
• Prospective Registration: Yes
• Primary sponsor: Johnson & Johnson Pharmaceutical Research & Development L.L.C
• Public title: A Study to Evaluate the Pharmacokinetics and Safety of Doripenem in Children and Adolescents with Cystic Fibrosis
• Scientific title: An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics and Safety of Doripenem in Pediatric Subjects 6 to 17 Years of age, Inclusive, With Cystic Fibrosis
• Target sample size: 22
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001225-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

United States

Contacts

• Name: Clinical Registry Group-JB BV
• Affiliation: Johnson & Johnson Pharmaceutical Research & Development

• Name: Clinical Registry Group-JB BV
• Affiliation: Johnson & Johnson Pharmaceutical Research & Development

Key inclusion & exclusion criteria

Inclusion criteria:
- Boy or girl between 6 years of age and 17 years of age, inclusive, with a confirmed diagnosis of CF (documented sweat chloride =60 mEq/L by quantitative pilocarpine iontophoresis test [QPIT] and/or homozygosity for ?F508 genetic mutation (or heterozygosity for 2 known mutations)
- Subjects must be medically stable, without acute decline in physical condition in the investigator's judgment.
- A parent or the subject's legally acceptable representative must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) and capable of providing it, as described in Section 11.2.3, Informed Consent/Assent and as approved by institutional-specific guidelines
- Suspected or diagnosed with an infection, colonization, or prophylaxis for which the subject is receiving antibiotic therapy
- Menarchal girls must be surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization, or abstinence for the duration of the study) before entry and throughout the study
- Menarchal girls, must have a negative urine pregnancy test at screening
- If a boy, must agree to use an adequate contraception method as deemed appropriate by the investigator (e.g., abstinence, vasectomy, double-barrier, partner using effective contraception)
- Be a non-smoker
Are the trial subjects under 18? yes
Number of subjects for this age range: 22
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- History of colonization with B. cepacia within the past 6 months
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening as deemed appropriate by the investigator. If the results of the chemistry, hematology, or urinalysis tests are outside normal reference ranges for a subject’s age, even if considered to be clinically significant, the subject can be included if, in the investigator's judgment, the abnormalities are consistent with the subject's underlying disease(s) or therapies. (Goss 2006) This determination must be recorded in the subject’s source documents and initialed by the investigator
- Clinically significant abnormal physical examination or vital signs at screening as deemed appropriate by the investigator. If the results of the physical examination or vital signs, are outside normal reference ranges for a subject’s age, even if considered to be clinically significant, the subject can be included if, in the investigator's judgment, the abnormalities are consistent with the subject's underlying disease(s) or therapies. (Goss 2006) This determination must be recorded in the subject’s source documents and initialed by the investigator
- History of clinically significant allergies to medications, especially known hypersensitivity or intolerance to carbapenems, penicillins, or other ß-lactam antibiotics
- Known allergy to heparin or history of heparin induced thrombocytopenia, if an indwelling cannula (e.g., heparin lock) or central line is used
- Subjects concomitantly treated with or having received imipenem/cilastin within 48 hours before study drug administration
- Subjects concomitantly treated with probenecid or VPA (refer to Section 5.5, Concomitant Therapy)
- Had substantial loss of blood (more than 10% of total blood volume) within 3 months before the administration of study drug
- Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug’s half-life, whichever is longer, before the administration of the study drug is scheduled
- If a menarchal girl, pregnant, breast-feeding or planning to become pregnant during the study
- Preplanned surgery or procedures that would interfere with the conduct of the study
- Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
- History of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or subject’s verbal report


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Cystic fibrosis
MedDRA version: 18.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Trade Name: DORIBAX
Product Name: DORIBAX
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: DORIPENEM HYDRATE
CAS Number: 364622-82-2
Other descriptive name: DORIPENEM HYDRATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Up to 10 days

Primary end point(s): Assess the pharmacokinetics, safety and tolerability of a single 30mg/kg dose of doripenem in pediatric subjects 6 to 17 years of age, with Cystic Fibrosis.

Main Objective: To assess the pharmacokinetics of doripenem after a single 30 mg/kg doripenem 4-hour i.v. infusion administered to pediatric subjects 6 to 17 years of age, inclusive, with cystic fibrosis (CF). Safety and tolerability will also be assessed.

Secondary Objective: Not applicable

Secondary Outcome(s)

Secondary end point(s): None

Timepoint(s) of evaluation of this end point: None

Secondary ID(s)

DORIPED1001

Source(s) of Monetary Support

Johnson & Johnson Pharmaceutical Research & Development