Not Yet RecruitingPhase 1ACTRN12618000350224

A study to evaluate the Safety and Pharmacokinetics (Pharmacokintecus, the measure of how the human body processes a substance) of ETX0282 when administered orally to healthy participants.

A Phase 1, Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of oral ETX0282 Administered in Healthy Subjects

Sponsor

INC Research/ Inventiv Health

Enrollment

116 participants

Start Date

Apr 2, 2018

Study Type

Interventional

Conditions

Enterobacteriaceae Infections

Summary

This research project is being conducted to investigate the safety, tolerability, and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Dose of oral ETX0282 when administered alone and in combination with Cefpodoxime Proxetil in healthy adult subjects.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria7

Aged 18 to 55 years (inclusive) In addition, for Cohort 6 in Part A, 8 subjects greater than or equal to 65 years of age will be enrolled.
Be in general good health without clinically significant medical history.
Provide voluntary written informed consent prior to any study procedures and are willing and able to comply with the prescribed treatment protocol and evaluations.
Body Mass Index (BMI) less than or equal to 32.0 kg/m2.
Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the Principal Investigator decided that out-of-range values are not clinically significant.
Negative screen for drugs of abuse, alcohol, hepatitis B surface antigen (HBSAg), hepatitis C virus antibody (HCV Ab), and human immunodeficiency virus (HIV) at screening; and drugs of abuse, alcohol predose on Day -1.
Female subjects must be of non-childbearing potential (postmenopausal or with evidence of tubal ligation) or using a medically acceptable (highly effective method) contraceptive regimen and must have a negative pregnancy test at screening (serum) and on Day -1 (urine) prior to study drug dosing. Male subjects must be surgically sterile or using a medically acceptable contraceptive regimen. Men should not donate sperm during the study or for 90 days after the final dose of study medication.

Exclusion Criteria13

History of any moderate or severe hypersensitivity or allergic reaction to any beta-lactam antimicrobial (e.g; penicillin or cephalosporin).
History of hypersensitivity or severe allergic reaction of any type to medications, bee stings, food, or environmental factors. A severe allergic reaction is defined as any of the following : anaphylaxis, urticarial, or angioedema.
Use of prescription or over-the-counter medications within 7 days of IP administration, with the exception of contraceptive medications, paracetamol, oral non-steroid anti-inflammatory agents, topical over-the-counter preparations, and routine vitamins (if they do not exceed an intake of 20 to 600 times the recommended daily dose), unless agreed as non-clinically relevant by the Principle Investigator and Sponsor.
Participation in an investigational drug or device study within 30 days before study drug dosing. i.e., there was at least 30 days between the last dose in a prior study and dose administration in this study.
Current smoker or difficulty abstaining from smoking for the duration of study confinement.
History of major organ dysfunction.
Infection or any serious underlying medical condition that would impair the subject from receiving study drug.
History of excessive alcohol intake (more than 4 standard drinks daily, on average) or use of recreational drugs within the last 3 months.
Standard donation of blood within 30 days of the study.
Concomitant disease or condition, including laboratory abnormality, which could interfere with the conduct of the study or which would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
Anticipated need for surgery or hospitalization during the study.
Surgery within 30 days before study enrollment..
Unwillingness or inability to comply with the study protocol for any other reason.

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Interventions

Part A - Single Ascending Dose (SAD) Cohort 1 : single dose 100mg oral ETX0282 or placebo Cohort 2: single dose 200mg oral ETX0282 or placebo Cohort 3: single dose 400mg oral ETX0282 or placebo Co

Part A - Single Ascending Dose (SAD) Cohort 1 : single dose 100mg oral ETX0282 or placebo Cohort 2: single dose 200mg oral ETX0282 or placebo Cohort 3: single dose 400mg oral ETX0282 or placebo Cohort 4: single dose 800mg oral ETX0282 or placebo Cohort 5: single dose 1600mg oral ETX0282 or placebo Cohort 6: single dose 800mg oral ETX0282 or placebo in elderly subjects (aged 65 years or older). Participants will be confined to the Study Unit from Day -1 and discharged following collection of the 72 hour post dose assessments (Day4). Part B - single dose ETX0282 Cohort 7: single dose 800mg oral ETX0282 or placebo (Day 1 ) while fasted and 800mg single oral dose of ETX0282 or placebo on (Day 4) with high-fat meal. Participants will be confined to the Study Unit from Day -1 and discharged following collection of the 72 hour post fed state dose assessments (Day 7 ). Part C - Multiple Ascending Dose (MAD) Cohort 8: single dose 100mg oral ETX0282 or placebo on morning (Day 1), Twice Daily dosing (Day 2 through Day 7) and single dose on morning of (Day 8). Cohort 9: single dose 200mg oral ETX0282 or placebo on morning (Day 1), Twice Daily dosing (Day2 through Day 7) and single dose on morning of (Day 8). Cohort 10: single dose 400mg oral ETX0282 or placebo on morning (Day 1), BID dosing (Day2 through Day 7) and single dose on morning of (Day 8). Cohort 11: single dose 800mg oral ETX0282 or placebo on morning (Day 1), Twice Daily dosing (Day2 through Day 7) and single dose on morning of (Day 8). Participants will be confined to the Study Unit from Day -1 and discharged following collection of the 72 hour post fed state dose assessments (Day 11). Part D - Single Dose ETX0282 in combination with Cefpodoxime Proxetil Cohort 12: Day 1 - single oral dose 800mg ETX0282 or placebo given in a fasted state Cohort 12: Day 4 - single oral dose 400mg Cefpodoxime Proxetil given in a fasted state Cohort 12: Day 7 - single oral dose 800mg ETX0282 or placebo plus 400mg oral dose Cefpodoxime Proxetil at the same time in a fasted state. Participants will be confined to the Study Unit from Day -1 and discharged following collection of the 72 hour post fed state dose assessments (Day 10). Part E - Multiple dose combination of ETX0282 and Cefpodoxime Proxetil Cohort 13: 800mg oral dose ETX0282 or placebo plus 400mg oral dose Cefpodoxime Proxetil given twice daily through (Day 10) and once on (Day 11) in a fasted state. Participants will be confined to the Study Unit from Day -1 and discharged following collection of the 72 hour post Day 11 dose assessments (Day 14). Drug will be prepared and administered by a qualified site pharmacist. Drug accountability will be performed by the pharmacists and monitored by the Unblinded CRA during the monitoring visits.