Safety and Pharmacokinetic (PK) Study to Assess Bronchopulmonary Disposition of IV Eravacycline (TP-434) in Healthy Men and Women

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1, open-label, randomized pharmacokinetic and safety study in healthy adult subjects, who will undergo bronchoscopy and bronchoalveolar lavage (BAL) after receiving seven (7) doses of 1.0 mg/kg IV TP-434.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tetraphase Pharmaceuticals, Inc.
• Collaborator: Department of Health and Human Services

Criteria

Inclusion Criteria:

1. Healthy males or non-pregnant, non-lactating healthy females

2. Age >18 to ≤ 65 years of age, inclusive

3. Body mass index of 18 to 33 kg/m2 or, if outside the range, considered not clinically significant by the Investigator

4. Must be willing and able to communicate and participate in the whole study

5. Must provide written informed consent

6. Must agree to use adequate methods of contraception

Exclusion Criteria:

1. Participation in a clinical research study within the previous 3 months

2. Subjects who have previously received TP-434

3. History of any drug or alcohol abuse in the past 2 years

4. Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)

5. Current smokers and those who have smoked within the last 6 months.

6. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator at screening

7. Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis as judged by the Investigator

8. Positive tests for drugs of abuse

9. Positive hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV; I and II) results

10. History of chronic respiratory disorders as judged by the Investigator

11. Serious adverse reaction or serious hypersensitivity to tetracyclines, midazolam or like compound, lidocaine or like compounds, or the formulation excipients

12. Donation or loss of greater than 400 mL of blood within the previous 3 months

13. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (with the exception of anti inflammatory, anti-hypertensive medications, or hormone replacement therapy) in the 14 days before Investigational Medicinal Product administration unless judged to not interfere with the study objectives according to the Investigator and sponsor's medical monitor

14. Failure to satisfy the Investigator of fitness to participate for any other reason