Study to Examine the Effect of Antacid and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects

Healthy Volunteers Clinical Trial

Official title:

An Open-Label, 3-Period, Fixed-Sequence, Study to Examine the Effect of Aluminum Hydroxide/Magnesium Hydroxide/Simethicone and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04368585
• Other study ID #: SPR994-107
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2020
• Est. completion date: August 21, 2020

Study information

• Verified date: September 2020
• Source: Spero Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the effect of a single dose of aluminum hydroxide/magnesium hydroxide/simethicone and omeprazole on the pharmacokinetics (PK) of TBPM, following a single dose of TBPM-PI-HBr in healthy adult subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 21, 2020
• Est. primary completion date: August 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Key Inclusion Criteria:

• Healthy, adult, male or female, 18-55 years of age, inclusive, at the screening visit.

• Continuous non-smoker

• Body mass index (BMI) = 18.0 and = 32.0 kg/m2 at the screening visit.

• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.

Key Exclusion Criteria:

• Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected to have during the conduct of the study.

• History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.

• History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.

• History of significant allergic disease requiring treatment

• History or presence of alcoholism or drug abuse within the past 2 years prior to the first dose.

• History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds (especially fluoroquinolone-, carbapenem-, penicillin-, and cephalosporin-antibiotics sensitivity).

• History of known genetic metabolism anomaly associated with carnitine deficiency (e.g., carnitine transporter defect, methylmalonic aciduria, propionic acidemia).

• History of cholecystectomy.

• Female subjects with a positive pregnancy test at the screening visit or first check-in or who are lactating.

• Positive urine drug or alcohol results at the screening visit or first check-in.

• Positive results at the screening visit for human immunodeficiency virus (HIV 1 and 2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)
Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally.
• 20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL)
20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL) oral suspension.
• Omeprazole
40 mg (1 x 40 mg capsule) omeprazole administered QD

Locations

Country	Name	City	State
United States	Medical Facility	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Spero Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t).		Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Primary	Area under the curve extrapolated to infinity (AUC0-8).		Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Primary	Percent of AUC0-inf extrapolated (AUC%extrap)		Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Primary	Maximum plasma concentration (Cmax).		Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Primary	Time to the maximum plasma concentration (Tmax).		Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Primary	Terminal elimination half-life (t½).		Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Primary	Apparent total body clearance (CL/F)		Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Primary	Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F).		Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Secondary	Incidence of treatment-emergent AEs (including SAEs) categorized by severity and relationship to study drug.	ECG, Clinical Laboratories, Vitals Signs and Physical Exams will be used as a safety measure to detect any AEs.	12 to 14 days after the last dose of study drug