Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects

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Spero Therapeutics

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference
Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test

Study type

Interventional

Funder types

Industry

Identifiers

NCT04421885
SPR994-105

Details and patient eligibility

About

A bioequivalence and food-effect study comparing two tablet formulations of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) in healthy adult subjects.

Enrollment

36 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy, adult, male or female, 18 to 55 years of age
  • Continuous non-smoker.
  • Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2.
  • Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs.
  • Has suitable venous access for repeated blood sampling.
  • A female of childbearing potential must agree to abstain from sexual activity that could lead to pregnancy.
  • A female of non-childbearing potential.
  • Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

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.
  • History of any illness that 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.
  • History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
  • History of known genetic metabolism anomaly associated with carnitine deficiency.
  • Female subjects with a positive pregnancy test or who are lactating.
  • Positive urine drug or alcohol results.
  • Positive results for human immunodeficiency virus (HIV 1 and 2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
  • QTcF interval is > 460 msec (males) or > 470 msec (females) or has ECG findings deemed abnormal with clinical significance by the PI or designee at the screening visit.
  • Estimated creatinine clearance < 80 mL/min at the screening visit.
  • Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

36 participants in 3 patient groups

A: TBPM-PI-HBr (Reference - fasted)
Experimental group
Description:
600 mg (2 x 300 mg tablets) clinical study drug product batch TBPM-PI-HBr administered at Hour 0 on Day 1, under fasted conditions.
Treatment:
Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference
B: TBPM-PI-HBr (Test - fasted)
Experimental group
Description:
600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr administered at Hour 0 on Day 1, under fasted conditions.
Treatment:
Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test
C: TBPM-PI-HBr (Test - fed)
Experimental group
Description:
600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr administered at Hour 0 on Day 1, under fed conditions.
Treatment:
Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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