Status:
COMPLETED
A Phase 1 TP-271 Oral PK Multiple Ascending Dose Study
Lead Sponsor:
Tetraphase Pharmaceuticals, Inc
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Bacterial Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This is a phase 1, single-center, randomized, placebo-controlled, double-blind, multiple ascending-dose study to assess the safety, tolerability, and PK of oral TP-271 in healthy adult subjects. Male ...
Detailed Description
This is a phase 1, single-center, randomized, placebo-controlled, double-blind, multiple ascending-dose study to assess the safety, tolerability, and PK of oral TP-271 in healthy adult subjects. Male ...
Eligibility Criteria
Inclusion
- Be within the age range of 18 to 50 years, inclusive, at the time of Screening
- 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 to and discussed with the subject and before undergoing any study-related procedures
- Have a body mass index (BMI) ≥18.0 and ≤33.0 kg/m2
- Have a negative history of and negative screening results for human immunodeficiency virus (HIV) types 1 and 2 and hepatitis B and C
- Have the ability to communicate with the study unit staff in a manner sufficient to carry out all protocol procedures as described
- Female subjects must be of non-childbearing potential, either 1-year postmenopausal or surgically sterile (i.e., bilateral oophorectomy, bilateral tubal ligation, or complete hysterectomy)
- Male subjects must be willing and able to use a barrier method of contraception or practice abstinence (including male subjects who had a vasectomy) from dosing to 90 days after final administration of the study drug
Exclusion
- 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, may either put the subject at risk due to participation in the study, influence the results of the study, or influence the subject's ability to participate in the study
- Clinical laboratory values that fall outside of the eligibility range specified in Appendix D are exclusionary; for clinical laboratory values that are not included in Appendix D, values outside of the reference range are exclusionary, except for those parameters listed in Table 4).
- Table 4 Acceptable Out-of-Range Clinical Laboratory Values
- Low Chemistry Values:
- Bicarbonate (a) Chloride GGT HDL cholesterol LDH LDL cholesterol Phosphorus
- High Chemistry Values:
- Chloride HDL cholesterol LDL cholesterol Phosphorus Triglycerides
- Out-of-Range Urinalysis Values; High or low specific gravity Cloudy Mucus Crystals Ketones (b) Hyaline casts High or low pH Urobilinogen (c)
- Out of Range Hematology Values; High hematocrit Basophils Monocytes MCV MCH MCHC RBC
- a Bicarbonate \>18 mEq/L. b Acceptable only when the concurrent blood glucose is normal. c Measured when monitoring the serum bilirubin concentration. Abbreviations: GGT = gamma-glutamyltransferase; HDL = high-density lipoprotein; LDH = lactate dehydrogenase; LDL = low-density lipoprotein; MCH = mean corpuscular hemoglobin; MCHC = mean corpuscular hemoglobin concentration; MCV = mean corpuscular volume; RBC = red blood cell.
- Known allergy to tetracycline antibiotics or any of the excipients in TP 271
- Clinically significant abnormality on a 12-lead ECG, which includes the following:
- Rhythm other than sinus
- Corrected QT interval using Fridericia's formula (QTcF) \>450 msec
- Evidence of second- or third-degree atrioventricular (AV) block
- Pathological Q-waves (defined as a 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 to be nonpathologic
- History of seizures
- History within 3 years of a positive result on a urine screen for drugs of abuse or a positive result on a urine screen at Screening for any of the following drugs of abuse: tetrahydrocannabinols, cocaine, opioids, phencyclidines, amphetamines, benzodiazepines, barbiturates, and cotinine
- Use of tobacco, nicotine, or nicotine-replacement products within 3 months prior to initial administration of study drug to the EOS Visit
- 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 of beer (12 oz), 1 glass of wine (approximately 4 to 5 oz), or distilled spirits (approximately 1 oz or 30 mL of liquor)
- Alcohol consumption within 48 hours prior to admission
- Participation in a clinical study within 10 half-lives of the prior study treatment or within the previous 3 months (if the half-life of investigational agent is unknown) prior to initial administration of study drug or planned participation in another clinical study concurrent with the present study
- History of difficulty donating blood or poor venous access
- Recent blood donation (1 unit or approximately 525 mL) within 1 month prior to receiving study drug or plans to donate prior to receiving study drug or during the clinical study
- 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 initial administration of study drug, with the following exceptions: medications used to treat an AE are permitted, and the use of acetaminophen, naproxen, and ibuprofen is permitted, except for within 24 hours prior to dosing
- Male subjects who donate or plan to donate sperm during the study or within 90 days after final administration of the study drug
- Unwillingness or inability to follow the procedures outlined in the clinical study protocol
- Previous participation in another TP-271 study
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03450187
Start Date
March 20 2018
End Date
March 31 2019
Last Update
December 17 2021
Active Locations (1)
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1
PPD Phase I Clinic
Austin, Texas, United States, 78744