A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014)



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:3/29/2019
Start Date:February 6, 2019
End Date:July 17, 2021
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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A Phase 1, Single-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old

The primary objectives of this study are to describe the single-dose pharmacokinetics (PK) of
intravenous (IV) tedizolid phosphate or an oral suspension of tedizolid phosphate, when
administered to pediatric participants, full-term neonates, and preterm neonates.


Inclusion Criteria:

- Is receiving prophylaxis for or has a confirmed or suspected infection with
gram-positive bacteria and receiving concurrent antibiotic treatment with gram
-positive antibacterial activity.

- Is at least 1 kg in weight; and weighs within >5th percentile and <95th percentile
based on age.

- Is in stable condition as determined from medical history, physical examination,
electrocardiogram (ECG), vital signs, and clinical laboratory evaluations.

- Has no clinically significant ECG abnormalities.

- Has sufficient vascular access to receive trial drug, and allow for required blood
draws.

- Is able to receive food and medication by mouth, for those dosed with oral suspension.

Exclusion Criteria:

- Has a history of seizures, other than febrile seizures, clinically significant cardiac
arrhythmia or condition, cystic fibrosis, moderate or severe renal impairment, or any
physical condition that could interfere with the interpretation of the study results,
as determined by the Investigator.

- Has used rifampin within 14 days prior to dosing.

- Has used or will be using ranitidine, cimetidine or antacids (for those taking oral
suspension dose) at any time from 24 hours prior to dosing through 24 hours after
dosing.

- Has a recent (3-month) history or current infection with viral hepatitis or other
significant hepatic disease.

- Has a history of drug allergy or hypersensitivity to oxazolidinones.

- Has had significant blood loss.

- Need for oral administration of topotecan, rosuvastatin, irinotecan, or methotrexate
during administration of oral study drug.

- Used monoamine oxidase inhibitors (MAOIs) or serotonergic agents including tricyclic
antidepressants, selective serotonin reuptake inhibitors (SSRIs), and serotonin
5-hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within 14
days prior to study, or planned use while on study.

- Has received another investigational product within the 30 days prior to enrollment.
We found this trial at
6
sites
1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Phone: 501-364-1416
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Phone: 714-509-4791
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Baton Rouge, Louisiana 70808
Phone: 225-765-5956
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Burgas,
Phone: +359884386907
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Saint Louis, Missouri 63110
Phone: 314-747-5128
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Saint Louis, MO
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Salt Lake City, Utah 84143
Phone: 801-587-6293
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Salt Lake City, UT
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