Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) Concentrations Following the Oral Administration of Five Doses of SPR994 in Healthy, Nonsmoking Volunteers

NCT ID: NCT04710407

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-07
• Study Completion Date: 2021-03-10

Brief Summary

To evaluate the intrapulmonary pharmacokinetics (PK), including ELF and AM concentrations, of SPR859 (tebipenem) compared to plasma concentrations of SPR859 (tebipenem) (the active moiety in plasma of the prodrug SPR994) in nonsmoking healthy adult volunteers.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TBPM-PI-HBr

Healthy subjects meeting eligibility criteria will receive a total of five doses of TBPM-PI-HBr 600 mg orally every 8 hours.

Group Type: EXPERIMENTAL

TBPM-PI-HBr

Intervention Type: DRUG

TBPM-PI-HBr (2 x 300mg tablets) a total of five doses

Interventions

TBPM-PI-HBr

TBPM-PI-HBr (2 x 300mg tablets) a total of five doses

Intervention Type: DRUG

Other Intervention Names

TBPM-PI-HBr oral capsule; SPR994

Eligibility Criteria

Inclusion Criteria

• Adult males or female subjects, between 18 and 55 years of age (both inclusive) at the time of screening
• BMI ≥ 18.5 and ≤ 32 (kg/m2) and weight between 55.0 and 100.0 kg (both inclusive)
• Willing and able to provide written informed consent; Willing and able to comply with all study assessments and adhere to the protocol schedule
• Medically healthy without clinically significant abnormalities as assessed by the Investigator based on screening medical history, physical examination, vital signs, 12-lead ECG, hematology, biochemistry and urinalysis
• Have suitable venous access for blood sampling

Exclusion Criteria

• History of seizure disorders
• Positive urine drug, alcohol or cotinine testing at screening or check-in (Day -1)
• Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HCV);
• Positive testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening;
• Presence of the following symptoms at screening or within 14 days prior to screening or Check-in (Day -1)

1. Fever, chills or sweats (temperature of 38 °C / 100.4 °F or higher)

2. Difficulty breathing

3. Cough

4. Sore throat

5. New or recent loss of taste or smell

6. Nausea, vomiting or diarrhea;

• Close contact with anyone who tested positive for SARS-CoV-2 infection within 14 days prior to screening or Check-in (Day -1);
• Electrocardiogram (ECG) with QTcF interval duration equal or greater than 450 msec for males and 470 msec for females
• Subjects who have any of the following abnormalities on laboratory values at screening or prior confinement including:

1. White blood cell count < 3,000/mm3, hemoglobin < 11g/dL;

2. Absolute neutrophil count <1,200/mm3, platelet count <120,000/mm3;

3. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 1.5 x the upper limit of normal (ULN) for the reference laboratory;

• History of substance abuse or alcohol abuse
• Use of tobacco/nicotine- or marijuana-containing products (including vaping products) within 12 months prior to screening;
• Known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinartis

INDUSTRY

Sponsor Role: collaborator

Spero Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Baratz, MD

Role: PRINCIPAL_INVESTIGATOR

Pulmonary Associates

Locations

Pulmonary Associates

Phoenix, Arizona, United States

Countries

United States

References

Rodvold KA, Gotfried MH, Gupta V, Ek A, Srivastava P, Talley A, Bruss J. Plasma and Intrapulmonary Concentrations of Tebipenem following Oral Administration of Tebipenem Pivoxil Hydrobromide to Healthy Adult Subjects. Antimicrob Agents Chemother. 2022 Jul 19;66(7):e0059022. doi: 10.1128/aac.00590-22. Epub 2022 Jun 28.

Reference Type: DERIVED

PMID: 35762796 (View on PubMed)

Other Identifiers

SPR994-108

Identifier Type: -

Identifier Source: org_study_id