A Phase 1 Safety and PK Study of IV TP-271

• Status: Unknown status
• Trial end date: 2019-02-28
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-center, randomized, placebo-controlled, double-blind, multiple-ascending-dose, inpatient study to assess the safety, tolerability, and pharmacokinetics of TP-271 in healthy subjects. Subjects aged 18 to 50 years who fulfill the inclusion/exclusion criteria will be enrolled in this study.

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

Details

• Lead Sponsor: Tetraphase Pharmaceuticals, Inc.
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)

Criteria

Inclusion Criteria:

1. Be within the age range of 18 to 50 years, inclusive, at the time of Screening

2. Voluntarily sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved ICF to participate in the study after all relevant aspects of the study have been explained and discussed with the subject and before undergoing any study-related procedures

3. Have a body mass index (BMI) ≥18.0 and ≤33.0 kg/m2

4. Have a negative history of and negative screening results for human immunodeficiency virus 1 and 2 and hepatitis B and C antibodies

5. Have the ability to communicate with the study unit staff in a manner sufficient to carry out all protocol procedures as described

6. For female subjects, be of non-childbearing potential, either 1 year postmenopausal or surgically sterile (bilateral oophorectomy, bilateral tubal ligation, or complete hysterectomy)

7. For male subjects, be willing and able to use a barrier method of contraception or practice abstinence (including males who had a vasectomy) from dosing through 90 days after administration of the final dose of study drug

Exclusion Criteria:

1. History and/or presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal, endocrine, psychiatric, or mental disease or disorder, or mental or legal incapacitation, which, in the opinion of the PI or Sub-Investigator(s), may either put the subject at risk because of participation in the study, influence the results of the study, or influence the subject's ability to participate in the study

2. Clinical laboratory values that fall outside the eligibility range specified in Appendix D; for laboratory values that are not included in Appendix D, values outside the reference range are exclusionary, with the following exceptions (Table 4. Acceptable Out-of-Range Clinical Laboratory Values

3. Known allergy to tetracycline antibiotics or to any of the excipients in TP-271

4. Clinically significant abnormality on a 12-lead ECG, including the following:

• Rhythm other than sinus

• Corrected QT interval using Fridericia's formula (QTcF) >450 msec

• Evidence of second- or third-degree atrioventricular block

• Pathological Q-waves (defined as Q-wave >40 msec or depth >0.4 to 0.5 mV)

• Evidence of ventricular pre-excitation

• Evidence of complete left bundle branch block (BBB), right BBB, or incomplete left BBB

• Intraventricular conduction delay with QRS duration >120 msec

• ST segment abnormalities, unless judged by the PI or Sub-Investigator(s) to be non pathologic

5. History of seizures

6. History within 3 years of a positive result on a urine screen for drugs of abuse or a positive result at Screening for any of the following drugs of abuse: tetrahydrocannabinols, cocaine, opioids, phencyclidines, amphetamine, benzodiazepine, and barbiturates

7. Use of tobacco, nicotine, or nicotine-replacement products within 3 months prior to administration of the study drug through the last visit

8. Typical weekly alcohol consumption of 7 or more alcoholic drinks, where 1 alcoholic drink is defined as 1 glass of beer (approximately 10 to 12 oz), 1 can (12 oz) of beer, 1 glass of wine (approximately 4 to 5 oz), or distilled spirits (approximately 1 oz or 30 mL of liquor)

9. Alcohol consumption within 48 hours prior to dosing

10. Participation in a clinical study within 10 half-lives of the prior study drug administration or within the previous 3 months if the half-life or dose of the investigational agent is unknown or planned participation in another clinical study concurrent with the current clinical study

11. History of difficulty donating blood or poor venous access

12. Blood donation (1 unit or approximately 350 mL) within 1 month prior to receiving study drug or plans to donate prior to receiving study drug or during the clinical study

13. Use of any prescription or nonprescription medication, including vitamins or herbal medications, vaccination, or immunization within 7 days or 5 half-lives (if known), whichever is longer, prior to dosing of study drug, with the following exceptions: medications used to treat an AE, and the use of acetaminophen, naproxen, and ibuprofen (except for within 24 hours prior to dosing)

14. Male subject donates or plans to donate sperm during the study and for at least 90 days after study drug administration.

15. Unwillingness or inability to follow the procedures outlined in the clinical study protocol