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

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. Identifier: NCT03775668
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : February 26, 2019
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: 1 µCi of 14C-AAI101 + 500 mg AAI101 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Single-Dose Study to Assess the Mass Balance, Pharmacokinetics and Metabolism of Intravenously Administered 14C-AAI101 in Healthy Male Subjects
Actual Study Start Date : November 27, 2018
Actual Primary Completion Date : December 5, 2018
Actual Study Completion Date : January 31, 2019

Arm Intervention/treatment
Experimental: 1 µCi of 14C-AAI101 + 500 mg AAI101
14C-AAI101 + 500 mg AAI101 iv infusion
Drug: 1 µCi of 14C-AAI101 + 500 mg AAI101
Single dose open label
Other Name: 14C-AAI101 + 500 mg AAI101 iv infusion

Primary Outcome Measures :
  1. Concentrations of total radiolabelled 14C-content in blood, plasma, urine, and feces. [ Time Frame: Up to 7 days post dosing ]
  2. Concentration of parent AAI101 in plasma and urine. [ Time Frame: Up to 7 days post dosing ]

Secondary Outcome Measures :
  1. Metabolite profiling for pooled plasma, urine and feces If > 10% of total radioactivity is recovered in the respective excreta sample/collection. [ Time Frame: Up to 7 days post dosing ]
  2. 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. [ Time Frame: Up to 7 days post dosing ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Ability to understand and willing to sign the Informed Consent Form (ICF)
  2. BMI 18.0 - 35.0 kg/m2, inclusive,
  3. Subjects with normal renal function as evidenced by creatinine clearance (CLcr).
  4. 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
  5. 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.

Exclusion Criteria:

  1. 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.
  2. Documented congenital or acquired long QT syndrome.
  3. Corrected QT interval (QTc) using Fridericia correction (QTcF) at Screening or pre dose (Day 1) >450 ms.
  4. Family history of long QT syndrome or of unexplained sudden death in a first-degree relative under age 50.
  5. History of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reaction.
  6. 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.
  7. 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.
  8. 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).
  9. Recent history of incomplete bladder emptying with voiding or of awaking more than once at night to void.
  10. Usual habit of less than one or more than three bowel movements per day.
  11. 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.
  12. Presence of active infection requiring antibiotic treatment.
  13. 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).
  14. Allergy, hypersensitivity or intolerance to β-lactam antibiotics and/or cephalosporin-class antibiotics in the medical history.
  15. Current smokers and those who have smoked within the last 12 months; this includes cigarettes, e-cigarettes and nicotine replacement or nicotine containing products.
  16. Participation in another investigational drug trial within 30 days prior to study drug administration (or 5 times the half-life of the drug, whichever is longer) or exposure to more than three new investigational agents within 12 months prior to study drug administration.
  17. Exposure to radiation for therapeutic or diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton) within the last 12 months prior to dosing of the investigational drug, or an occupationally exposed worker
  18. Participation in another clinical trial in which a [14C]-labeled drug was administered within the year prior to Day -1.
  19. Donation or loss of more than 450 mL blood during the 3 months before the start of and during Screening.
  20. Serum Alkaline phosphatase (AP) > 1.5x upper limit of normal (ULN).
  21. Serum transaminase [alanine aminotransferase (ALT) or aspartate aminotransferase (AST)] > ULN.
  22. Serum uric acid > ULN.
  23. Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti HCV) or human immunodeficiency virus antibodies (anti-HIV)-1/2 at Screening.
  24. Positive urine screen of drugs of abuse or alcohol breath test at Screening and/or Day 1.
  25. Strenuous or unaccustomed activity, sunbathing, or contact sports within 96 hours (4 days) prior to entry in the clinic research center.
  26. Legal incapacity or limited legal capacity.
  27. Any clinically significant medical condition, i.e., one which in the opinion of the Investigator would increase risk to the subject's health if participating in this study or would increase risk of not achieving the study objectives.
  28. Use of any prescription or non-prescription drugs, including over-the-counter medication, non-routine vitamins and herbal products within 2 weeks prior to study drug administration unless discussed and agreed with the Sponsor's medical representative in writing.


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 identifier (NCT number): NCT03775668

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United States, Maryland
Pharmaron Clinical Pharmacology Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
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Responsible Party: Allecra Identifier: NCT03775668    
Other Study ID Numbers: AT-104
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No