Status:
COMPLETED
Effect of Tebipenem on Normal Human Intestinal Microbiota
Lead Sponsor:
Spero Therapeutics
Collaborating Sponsors:
Iqvia Pty Ltd
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The overall purpose of this study is to support the development of an oral formulation of TBPM-PI-HBr by assessing the potential ecological effects of tebipenem on the normal intestinal microbiota as ...
Detailed Description
This is a single-center, open-label, randomized, parallel-group, active-control, phase 1 study consisting of 10-day treatment period using TBPM-PI-HBr (600mg) (2× 300mg film coated tablets) or amoxici...
Eligibility Criteria
Inclusion
- Healthy adult males and/or females, ≥18 years of age at the time of screening;
- Medically healthy without clinically significant abnormal values for hematology, clinical chemistry, urinalysis, physical examination, vital signs, or ECG as determined by the investigator during the screening period. Discussion is encouraged between the Investigator and the Sponsor Medical Monitor regarding the clinical relevance of any abnormal laboratory value during the pre-dose period;
- Willing and able to provide written informed consent;
- Willing and able to comply with all study assessments and adhere to the protocol schedule, including all scheduled post-therapy visits;
- Have suitable venous access for blood sampling;
- Women of childbearing potential (WOCBP\*) must use a highly effective form of birth control (confirmed by the Investigator). Rhythm methods will not be considered as highly effective methods of birth control. WOCBP must agree to use a highly effective method of birth control, as defined above, from signing the Informed Consent Form (ICF), throughout the study duration and until 30 days after the last dose of study drug;
- Non-vasectomized male volunteers must use an adequate method of contraception (condom or condom with spermicide, depending on local regulations) from the time of signing the ICF, throughout the study duration and until 30 days after the last dose of study drug. Men with a partner who is (are) not of childbearing potential are exempt from these requirements;
- Male volunteers must not donate sperm for time of signing the ICF until at least 30 days after the last dose of the study drug
Exclusion
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the Investigator to be clinically relevant;
- History or presence of known or suspected gastrointestinal disorder, including but not limited to Clostridioides difficile infection, inflammatory bowel disease, recent history of food poisoning or other stomach/intestinal disorders including gastroenteritis (within 6 months);
- History of systemic antibiotic treatment during the last three months prior to randomization;
- Use of any systemic prescription medication or any systemic over-the-counter medication, including herbal products and vitamins or probiotics within 7 days prior to randomization; except for hormonal contraceptives and the intermittent use of paracetamol, ibuprofen, and antihistamines;
- Alanine transaminase (ALT) or aspartate transaminase (AST) \>5 × upper limit of normal and CrCl of ≤50 mL/min, as estimated by the Lund-Malmö revised formula;
- History of seizure disorders, except for febrile seizures in childhood;
- History of substance or alcohol abuse and positive urine drug testing at screening. History of substance or alcohol abuse and negative urine drug testing at screening can be enrolled in study based on the Investigator's discretion;
- Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV);
- Documented or suspected hypersensitivity reaction or anaphylaxis to β-lactam antibiotics (e.g., cephalosporins, penicillins, carbapenems), product excipients (Mannitol, microcrystalline cellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, and film coating systems \[Opadry\]) or any contraindication to the use of amoxicillin- clavulanate;
- Participation in another investigational clinical study within 3 months prior to Day 1;
- Current or anticipated need for systemic antibiotics, probiotics, or laxatives during the study;
- Any other condition or prior therapy, which, in the opinion of the Investigator, would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likely to be non-compliant with any study requirements.
Key Trial Info
Start Date :
February 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04376554
Start Date
February 10 2020
End Date
April 6 2021
Last Update
May 4 2021
Active Locations (1)
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1
Karolinska University Hospital
Huddinge, Stockholm County, Sweden