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Clinical trial

A Phase 1, Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intravenous and Oral Doses of Omadacycline in Pediatric Subjects With Suspected or Confirmed Bacterial Infections

ID
Name
PTK0796-PEDPK-20110
Description
The purpose of this study is to evaluate the pharmacokinetics of a single dose of intravenous or oral omadacycline in children and adolescents with suspected or confirmed bacterial infections.
Trial arms
Trial start
2022-04-06
Estimated PCD
2024-09-01
Trial end
2024-09-01
Status
Recruiting
Phase
Early phase I
Treatment
Omadacycline Injection [Nuzyra]
Single dose of 100 mg omadacycline IV in 100 mL of normal saline
Arms:
Cohort 1 (adolescents), Cohort 2 (children)
Other names:
NUZYRA
Omadacycline Oral Tablet
Single dose of 300 mg omadacycline PO (2 x 150 mg tablets)
Arms:
Cohort 1 (adolescents), Cohort 2 (children)
Other names:
NUZYRA
Size
40
Primary endpoint
Characterize the PK of a single IV dose of omadacycline in children and adolescents 8 to < 18 years of age with suspected or confirmed bacterial infections
Pre-dose, and 0.5, 1, 2, 8, and 24 hours post-dose
Characterize the PK of a single PO dose of omadacycline in children and adolescents 8 to < 18 years of age with suspected or confirmed bacterial infections
Pre-dose, and 1, 2, 3, 8, and 24 hours post-dose
Eligibility criteria
Inclusion Criteria: * Male or female subjects, age 8 to \< 18 (inclusive) who have written and signed parental/legal authorized representative (LAR) informed consent and pediatric assent. * Currently hospitalized with a suspected or confirmed bacterial infection and receiving or planned to receive systemic antibiotic therapy other than omadacycline. * Weight within the 5th and 95th percentile for age and sex. * Subjects must not be pregnant or nursing at the time of enrollment, and must agree to use a highly effective birth control method during the study Exclusion Criteria: * Evidence of a medical condition that may pose a safety risk or impair study participation. * Confirmed or suspected SARS-CoV-2 infection. * Has a history of hypersensitivity or allergic reaction to any tetracycline antibiotic. * Has received an investigational drug within the past 30 days.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-02-16

1 organization

2 products

1 indication

Organization
Paratek Pharmaceuticals
Product
Omadacycline
Indication
Bacterial Infections
Product
Omadacycline Injection