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A Single-Dose, Randomized, Placebo- and Active-Control, Four-Way, Cross-Over Study for the Evaluation of the Effect of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) on the QT/QTc Intervals in Adult Healthy Subjects
Phase 1
Waitlist Available
Research Sponsored by Spero Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose through 24 hours post-dose
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Summary
This is a randomized, double-blind (with respect to Tebipenem pivoxil hydrobromide \[TBPM-PI-HBr\]/placebo only), placebo- and active-control, single-dose, 4-way crossover study that will enroll 24 healthy adult male and female subjects. There will be a washout period of at least 7 days between dosing in each period and each subject will receive all 4 treatments over 4 periods in a crossover study design.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose through 24 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose through 24 hours post-dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To evaluate the effect of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr on the heart rate corrected QT interval (QTc) by assessing concentration-QT (C-QT) relationship using exposure-response modeling.
Secondary study objectives
Electrocardiogram
2. To evaluate pharmacokinetics (PK) of tebipenem (TBPM) after administration of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr.
3. To assess the safety and tolerability of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr.
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment DExperimental Treatment1 Intervention
Positive Control - unblinded: 400 mg moxifloxacin (1 x 400 mg tablet) administered at Hour 0 on Day 1.
Group II: Treatment BExperimental Treatment1 Intervention
1200 mg TBPM-PI-HBr (4 x 300 mg tablets) administered at Hour 0 on Day 1.
Group III: Treatment AExperimental Treatment2 Interventions
600 mg TBPM-PI-HBr (2 x 300 mg tablets) and TBPM-PI-HBr-matching placebo (2 x matching placebo tablets) administered at Hour 0 on Day 1.
Group IV: Treatment CPlacebo Group1 Intervention
TBPM-PI-HBr-matching placebo (4 x matching placebo tablets) administered at Hour 0 on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) + Placebo
2020
Completed Phase 1
~30
Moxifloxacin
FDA approved
Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)
2020
Completed Phase 1
~30
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
CelerionIndustry Sponsor
84 Previous Clinical Trials
7,906 Total Patients Enrolled
Spero TherapeuticsLead Sponsor
22 Previous Clinical Trials
4,812 Total Patients Enrolled