Absorption, Metabolism, and Excretion Study of [14C]-TNP-2092

NCT05074134 | Completed Phase 1 FDA Drug

• 1 other identifier: TNP-2092-IV-08
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single dose, Phase 1 study conducted at a single study center in the United States (USA). This study will evaluate the absorption, metabolism and elimination (AME), mass balance, safety and tolerability of a single dose of intravenously administered \[14C\]-TNP-2092. Healthy men aged 18 to 55, will be screened, and subjects who meet all eligibility criteria and provide written informed consent will be enrolled into the study within 28 days of Screening. Subjects will be admitted to the clinical unit on the day prior to dosing (Day -1). Subjects will fast overnight and then given a standard breakfast 30 min prior to dosing. Six subjects will be enrolled in the study and each will receive a single intravenous (IV) dose of 300 mg/3 μCi \[14C\]-TNP-2092 administered over 60 minutes (±10 minutes).

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Mass balance of TNP-2092 and the percentages of radiolabel recovered in urine and feces

  Percent (%) for each radiolabeled drug-related material will be determined in plasma,urine and feces.

  Day 7

• Pharmacokinetics (PK) of TNP-2092 in plasma

  AUC(Area under the plasma concentration) will be determined, using Linear/Log trapezoidal method, from plasma concentration data for TNP-2092

  Day 7

• Pharmacokinetics (PK) of TNP-2092 in plasma

  t1/2 (apparent terminal elimination half life) will be estimated for TNP-2092 from the terminal portion of its plasma concentration versus time plot

  Day 7

Secondary Outcomes (1)

• Routes and rates of elimination of [14C] TNP 2092

  Day 7

Study Arms (1)

[14C]-TNP-2092

EXPERIMENTAL

Drug: [14C]-TNP-2092

Interventions

[14C]-TNP-2092 DRUG

Subjects will receive a single intravenous (IV) dose of 300 mg/3 µCi \[14C\]-TNP-2092 administered over 60 minutes (± 10 minutes).

[14C]-TNP-2092

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Capable of understanding the written informed consent form (ICF), willingly provide valid, signed written informed consent, and willing and able to comply with the schedule, requirements, and restrictions of the study
• Males between 18 and 55 years of age (inclusive) at the time of Screening
• Body mass index (BMI) ≥18.0 kg/m2 and ≤32.0 kg/m2 at Screening; body weight ≥55.0 kg and ≤100.0 kg at Screening
• Considered to be in good health by the Investigator, as determined by medical history, physical examination, VS measurements, 12-lead ECG, and clinical laboratory test results
• Male subjects with female sexual partner(s) of reproductive potential may be enrolled if the male:
• is documented to be surgically sterile (i.e., successfully vasectomized), or
• agrees to use 2 methods of highly effective contraception and agree to refrain from sperm donation from the time of Screening through 90 days post dose
• Negative serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), and human immunodeficiency virus antibody (HIV Ab)
• Non-smoker (with no use of other tobacco or nicotine containing products, in any form), as documented by history (no nicotine within 6 months prior to Screening) and a negative cotinine test at Screening and Admission See Section 5.3 for details of nicotine and tobacco restrictions
• Negative results for drugs of abuse and alcohol at Screening and Admission
• Content of 14C in urine, whole blood, and/or plasma (per Investigator discretion) samples obtained at Screening does not significantly exceed the general environmental background 14C level At present, background level of 14C is 104 percent Modern Carbon (pMC). To be eligible for study enrollment, subjects must have ≤30 pMC in a plasma or urine sample analyzed with sodium benzoate carbon carrier or ≤150 pMC for a sample analyzed directly (with no carbon carrier).
• Willing to comply with Pharmaron's COVID-19 policies.

You may not qualify if:

• Any contraindication to the use of rifampin/rifamycin or a fluoroquinolone
• History or presence of any condition (e.g., chronic diarrhea) or prior surgery (e.g., gastric bypass) that, in the opinion of the Investigator, poses a significant risk to subject safety and/or achievement of study objectives
• Clinically significant abnormal medical history, or any abnormal findings on physical examination, VS, ECG, or laboratory tests at Screening, Admission, or pre dose on Day 1 that, in the opinion of the Investigator, could jeopardize achieving the study objectives and/or compromise the subject's safety
• History of cancer that has not been in full remission for \>5 years (except basal cell skin cancer or squamous cell skin cancer with history of curative treatment and no recurrence for \>1 year prior to Screening), as judged by the Investigator
• Acute illness within 14 days prior to study drug administration on Day 1, unless mild in severity and enrollment is approved by both the Investigator and Sponsor's medical representative
• COVID-19 positive for active disease
• Any history of allergic drug reactions
• History or presence of alcohol or drug abuse within 2 years prior to Screening
• Recent history of incomplete bladder emptying with voiding or awakening more than once at night to void
• Usual habit of \<1 or \>3 bowel movements per day
• Exposure to radiation for therapeutic or diagnostic reasons (except dental X rays and plain X rays of thorax and bony skeleton) within the past 12 months prior to study drug administration on Day 1, or worker occupationally exposed to radiation
• Participation in another clinical study in which a \[14C\] labeled drug was administered within 1 year prior to Admission
• Administration of another investigational medication within 30 days (or 5 half lives, whichever is longer) prior to study drug administration
• Participation in an investigational device study within 30 days prior to study drug administration
• Any ECG abnormality considered to be clinically significant by the Investigator

Sponsors & Collaborators

• TenNor Therapeutics Limited: lead

Study Sites (1)

Pharmaron Clinical Pharmacology Center

Baltimore, Maryland, 21201, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: October 16, 2021
• Primary Completion: November 30, 2021
• Study Completion: July 12, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)