Single Dose Mass Balance Study With C14 - Labeled AAI101 in Healthy Male Volunteers

NCT03775668 | Completed Phase 1 FDA Drug

• 1 other identifier: AT-104
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single dose, pharmacokinetic (PK) study conducted at 1 study center in the United States (USA). This study will evaluate the absorption, distribution, metabolism, and elimination (ADME), mass balance, safety, and tolerability of a single dose of intravenously administered 14C-AAI101.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Concentrations of total radiolabelled 14C-content in blood, plasma, urine, and feces.

  Up to 7 days post dosing

• Concentration of parent AAI101 in plasma and urine.

  Up to 7 days post dosing

Secondary Outcomes (2)

• Metabolite profiling for pooled plasma, urine and feces If > 10% of total radioactivity is recovered in the respective excreta sample/collection.

  Up to 7 days post dosing

• Calculation of cumulative urinary and fecal recovery of total radioactivity, and calculation of mass balance as a sum of the percentages of total radioactivity recovered in urine and feces.

  Up to 7 days post dosing

Study Arms (1)

1 µCi of 14C-AAI101 + 500 mg AAI101

EXPERIMENTAL

14C-AAI101 + 500 mg AAI101 iv infusion

Drug: 1 µCi of 14C-AAI101 + 500 mg AAI101

Interventions

1 µCi of 14C-AAI101 + 500 mg AAI101 DRUG

Single dose open label

Also known as: 14C-AAI101 + 500 mg AAI101 iv infusion

1 µCi of 14C-AAI101 + 500 mg AAI101

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and willing to sign the Informed Consent Form (ICF)
• BMI 18.0 - 35.0 kg/m2, inclusive,
• Subjects with normal renal function as evidenced by creatinine clearance (CLcr).
• Judged to be in good health in the opinion of the Investigator on the basis of a medical evaluation that reveals the absence of any clinically significant abnormality
• Content of 14C in one or both (at Investigator's discretion) of urine and blood (or plasma) samples obtained at Screening does not significantly exceed the general environmental background 14C level.

You may not qualify if:

• Clinically significant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at Screening, Day -1 or pre-dose on Day 1 that the Investigator judges may put at risk achieving the objectives of the trial or protecting the safety of the volunteer.
• Documented congenital or acquired long QT syndrome.
• Corrected QT interval (QTc) using Fridericia correction (QTcF) at Screening or pre dose (Day 1) \>450 ms.
• Family history of long QT syndrome or of unexplained sudden death in a first-degree relative under age 50.
• History of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reaction.
• History of cancer judged not to be in full remission for at least 5 years (except basal cell skin cancer or squamous cell skin cancer with history of curative treatment and no recurrence for at least 1 year), as judged by the Investigator.
• History of active alcoholism or drug abuse within the last 2 years prior to study drug administration. Acceptable use history is typical consumption of up to 14 units per week (1 unit equals 250 mL beer, 75 mL wine, 25 mL spirits per week), or per judgment of the Investigator.
• Regular alcohol consumption in males \>14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type).
• Recent history of incomplete bladder emptying with voiding or of awaking more than once at night to void.
• Usual habit of less than one or more than three bowel movements per day.
• Acute illness within 14 days prior to study drug administration unless mild in severity and enrollment is approved by both Investigator and Sponsor's medical representative.
• Presence of active infection requiring antibiotic treatment.
• Concomitant or prior use (within 60 days prior to study drug administration) of medications known to affect the elimination of serum creatinine (e.g., trimethoprim or cimetidine) or to compete for renal tubular secretion (e.g., probenecid).
• Allergy, hypersensitivity or intolerance to β-lactam antibiotics and/or cephalosporin-class antibiotics in the medical history.
• Current smokers and those who have smoked within the last 12 months; this includes cigarettes, e-cigarettes and nicotine replacement or nicotine containing products.

Sponsors & Collaborators

• Allecra: lead

Study Sites (1)

Pharmaron Clinical Pharmacology Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

enmetazobactam

Study Design

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

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 14, 2018
• Study Start: November 27, 2018
• Primary Completion: December 5, 2018
• Study Completion: January 31, 2019
• Last Updated: February 26, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)