Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents

Melinta Therapeutics

Status and phase: Completed; Phase 1

Conditions: Bacterial Infections

Treatments: Drug: Solithromycin

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT01966055

CE01-119

Details and patient eligibility

About

A study of the safety and pharmacokinetics of solithromycin capsules in adolescents

Enrollment: 13 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 12 to 17 yo male or female with suspected or confirmed bacterial infection

Exclusion criteria

• Bacterial meningitis
• Clinical significant concomitant medical condition

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Solithromycin

Experimental group

Treatment:

Drug: Solithromycin