Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368585
Recruitment Status : Completed
First Posted : April 30, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Spero Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) Drug: 20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL) Drug: Omeprazole Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : July 1, 2020
Actual Primary Completion Date : August 8, 2020
Actual Study Completion Date : August 21, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TBPM-PI-HBr Alone (Period 1)
Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally alone.
Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)
Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally.
Other Names:
  • TBPM-PI-HBr
  • SPR994

Experimental: TBPM-PI-HBr and Antacid (Period 2)
20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL) oral suspension will be coadministered with 600 mg (2 x 300 mg tablets) TBPM-PI-HBr at Hour 0 on Day 1.
Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)
Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally.
Other Names:
  • TBPM-PI-HBr
  • SPR994

Drug: 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.

Experimental: TBPM-PI-HBr and Omeprazole (Period 3)
40 mg (1 x 40 mg capsule) omeprazole administered QD at Hour -2 on Days 1 through 5, with 600 mg (2 x 300 mg tablets) TBPM-PI-HBr administered at Hour 0 on Day 5.
Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)
Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally.
Other Names:
  • TBPM-PI-HBr
  • SPR994

Drug: Omeprazole
40 mg (1 x 40 mg capsule) omeprazole administered QD




Primary Outcome Measures :
  1. Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t). [ Time Frame: Day 2 (Periods 1 and 2) and Day 6 (Period 3) ]
  2. Area under the curve extrapolated to infinity (AUC0-∞). [ Time Frame: Day 2 (Periods 1 and 2) and Day 6 (Period 3) ]
  3. Percent of AUC0-inf extrapolated (AUC%extrap) [ Time Frame: Day 2 (Periods 1 and 2) and Day 6 (Period 3) ]
  4. Maximum plasma concentration (Cmax). [ Time Frame: Day 2 (Periods 1 and 2) and Day 6 (Period 3) ]
  5. Time to the maximum plasma concentration (Tmax). [ Time Frame: Day 2 (Periods 1 and 2) and Day 6 (Period 3) ]
  6. Terminal elimination half-life (t½). [ Time Frame: Day 2 (Periods 1 and 2) and Day 6 (Period 3) ]
  7. Apparent total body clearance (CL/F) [ Time Frame: Day 2 (Periods 1 and 2) and Day 6 (Period 3) ]
  8. Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F). [ Time Frame: Day 2 (Periods 1 and 2) and Day 6 (Period 3) ]

Secondary Outcome Measures :
  1. Incidence of treatment-emergent AEs (including SAEs) categorized by severity and relationship to study drug. [ Time Frame: 12 to 14 days after the last dose of study drug ]
    ECG, Clinical Laboratories, Vitals Signs and Physical Exams will be used as a safety measure to detect any AEs.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368585


Locations
Layout table for location information
United States, Arizona
Medical Facility
Phoenix, Arizona, United States, 85283
Sponsors and Collaborators
Spero Therapeutics
Investigators
Layout table for investigator information
Study Director: David Melnick, M.D. Spero Therapeutics
Layout table for additonal information
Responsible Party: Spero Therapeutics
ClinicalTrials.gov Identifier: NCT04368585    
Other Study ID Numbers: SPR994-107
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Simethicone
Omeprazole
Aluminum Hydroxide
Magnesium Hydroxide
Aluminum hydroxide, magnesium hydroxide, drug combination
Aluminum hydroxide, magnesium hydroxide, simethicone drug combination
TEMPO
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifoaming Agents
Emollients
Dermatologic Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antacids
Antioxidants
Protective Agents