A Phase 1 Study to Evaluate Safety, Tolerability, PK, and PK Interactions of TBA-7371

Completed · Phase 1 · Has a placebo group

Conditions studied: Tuberculosis, Tuberculosis, Pulmonary

In brief

The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of TBA-7371 in healthy subjects

Key facts

Study ID

NCT03199339

Run by

Global Alliance for TB Drug Development

People needed

74

Starts

2017-08-29

Expected to finish

2018-07-08

Last updated by the study team

2018-10-17

Who can join

Age: 19 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must fulfill all of the following inclusion criteria and none of the exclusion criteria to be eligible for participation in the study, unless otherwise specified.
• Healthy adult male and females of non-childbearing potential, 19 to 50 years of age (inclusive) at the time of screening.
• Body mass index (BMI) ≥ 18.5 and ≤ 32.0 (kg/m2) and a body weight of no less than 50.0 kg.
• Medically healthy with no clinically significant screening results (e.g., laboratory profiles, medical histories, vital signs, ECGs, physical examination) as deemed by the Investigator.
• No use of tobacco or nicotine containing products (including smoking cessation products), for a minimum of 6 months prior to dosing.
• Females of non-childbearing potential, having undergone one of the following sterilization procedures at least 6 months prior to dosing:
• i. Hysteroscopic sterilization ii. Bilateral tubal ligation or bilateral salpingectomy iii. Hysterectomy iv. Bilateral oophorectomy v. or be postmenopausal with amenorrhea for at least 1 year prior to the first dose with serum follicle stimulating hormone (FSH) levels consistent with postmenopausal status at screening.
• Non-vasectomized males (or males vasectomized less than 120 days prior to study start), must agree to the following during study participation and for 90 days following the last administration of study drug:
• use a condom with spermicide while engaging in sexual activity or be sexually abstinent
• not donate sperm during this time. In the event the sexual partner is surgically sterile, use of a condom with spermicide is not necessary. None of the restrictions listed above are required for vasectomized males whose procedure was performed more than 120 days prior to study start.
• Willing to answer inclusion and exclusion criteria questionnaire at check-in.
• Subject understands study procedures and provides written informed consent for the trial.
• Be able to comply with the protocol and the assessments therein, including all restrictions.
• Is willing and able to remain in the study unit for the entire duration of the assigned confinement period and return for outpatient visits.
• If enrolled in Part 1 and assigned to the fasted/fed cohort, is willing and able to consume the entire high-calorie, high-fat breakfast meal in the timeframe required.

You may not qualify if…

• Subjects will be excluded from the study if there is evidence of any of the following criteria at screening or check-in, as appropriate.
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease as determined by the Investigator to be clinically relevant.
• History of any illness that, in the opinion of the Investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
• Surgery within the past 90 days prior to dosing as determined by the Investigator to be clinically relevant, or any history of cholecystectomy.
• History or presence of alcoholism or drug abuse within the past 2 years as determined by the Investigator to be clinically relevant.
• Female subjects who are pregnant or lactating.
• Positive results for the urine drug/alcohol screen at screening or check-in.
• Positive urine cotinine at screening or check in.
• Serum magnesium potassium, or calcium laboratory values outside of the normal range at screening.
• Positive results at screening for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCV).
• Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening, Day -2 (check-in), Day -1, or predose. Out-of-range vital signs may be repeated once for confirmation.
• Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening, Day -2 (check-in), Day -1, or predose. Out-of-range vital signs may be repeated once for confirmation.
• Any electrocardiogram abnormality at Screening (as deemed by decision of the Investigator and the Sponsor's Medical Monitor).
• NOTE: The following can be considered not clinically significant without consulting the Sponsor's Medical Monitor:
• i. Mild first degree A-V block (P-R interval <0.23 sec) ii. Right or left axis deviation iii. Incomplete right bundle branch block iv. Isolated left anterior fascicular block (left anterior hemiblock) in younger athletic subjects
• QTcF interval >450 msec for males or >470 msec for females at screening, Day -2, Day -1, or Day 1 (pre-dose), or history of prolonged QT syndrome.
• Family history of Long-QT Syndrome or sudden death without a preceding diagnosis of a condition that could be causative of sudden death (such as known coronary artery disease, congestive heart failure or terminal cancer).
• History of one or any combination of, the following:
• i. Seizures or seizure disorders ii. Brain surgery. iii. History of head injury in the last five years iv. Any serious disorder of the CNS or related neurological system, particularly one that may lower the seizure threshold.
• v. History of seizures
• Use of any prescription medication within 14 days prior to dosing.
• Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to dosing, except acetaminophen. Up to 3 grams per day of acetaminophen is allowed at the discretion of the Investigator prior to dosing.
• Use of any drugs or substances known to be significant inhibitors of Cytochrome P450 (CYP) enzymes and/or significant inhibitors or substrates of P-glycoprotein (P-gp) and/or Organic anion transporting polypeptides (OATP) within 14 days prior to the first dose of study drug.
• Use of any drugs or substances known to be inducers of CYP enzymes and/or P-gp, including St. John's Wort, within 30 days prior to the first dose of study drug.
• Use of any drugs or substance known to lower the seizure threshold.

Where it is running

• Worldwide Clinical Trials — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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