NCT04376554

Effect of Tebipenem on Normal Human Intestinal Microbiota

Phase 1 Study to Evaluate the Effect of Oral Administration of Tebipenem Pivoxil Hydrobromide on Normal Human Intestinal Microbiota in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Spero Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 compared to the effects of oral amoxicillin-clavulanate.

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 amoxicillin-clavulanate (500mg/125mg) orally every 8 hours (PO q8h \[±1 hour\]) in healthy volunteers. Participants will be randomized by gender to 1:1 ratio on Day 1. A maximum of 30 participants will be randomly assigned to the study treatment groups (15 in each arm) such that approximately 24 evaluable participants complete the study. Due to the multidimensional nature of data of the study, a power statement on a single endpoint is not appropriate. The main aim of the study is to estimate the effects of treatment on the intestinal microbiota, and to assess the pattern of susceptibility to specific pathogens. Based upon previous studies, a sample size of 12 participants in each group is considered sufficient to demonstrate a clinically significant impact of antibiotics on the microbiota. Total duration of study participation for each participant will be approximately 7 months.Screening visit will be performed between Day -28 to Day -1. Randomization will be performed on Day 1 and with treatment being administered from Day 1 to Day 10. Follow-up of participants will occur on Day 14, 21, 90 and 180 with appropriate visit windows. Adverse events and concomitant medications will be recorded until the end of the study (Day 180).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	TBPM-PI-HBr	TBPM-PI-HBr (2 x 300mg tablets) PO q8h \[±1 hour\] for 10 days
DRUG	amoxicillin-clavulanate	amoxicillin-clavulanate (1 × 500mg/125mg tablet) PO q8h \[±1 hour\] for 10 days

Timeline

• Start date: 2020-02-10
• Primary completion: 2021-04-06
• Completion: 2021-04-06
• First posted: 2020-05-06
• Last updated: 2021-05-04

Locations

1 site across 1 country: Sweden

Regulatory

• FDA-regulated drug study