HealthyPhase 1NCT03775668
Single Dose Mass Balance Study With C14 - Labeled AAI101 in Healthy Male Volunteers
A Phase 1 study testing 1 µCi of 14C-AAI101 + 500 mg AAI101 in people with Healthy, run by Allecra at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 1 µCi of 14C-AAI101 + 500 mg AAI101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2018to 31 Jan 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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.
- 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
- Participation in another clinical trial in which a [14C]-labeled drug was administered within the year prior to Day -1.
- Donation or loss of more than 450 mL blood during the 3 months before the start of and during Screening.
- Serum Alkaline phosphatase (AP) > 1.5x upper limit of normal (ULN).
- Serum transaminase [alanine aminotransferase (ALT) or aspartate aminotransferase (AST)] > ULN.
- Serum uric acid > ULN.
- 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.
- Positive urine screen of drugs of abuse or alcohol breath test at Screening and/or Day 1.
- Strenuous or unaccustomed activity, sunbathing, or contact sports within 96 hours (4 days) prior to entry in the clinic research center.
- Legal incapacity or limited legal capacity.
- 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.
- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaron Clinical Pharmacology Center
Baltimore, Maryland, 21201
About this study
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
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
- Being tested
- 1 µCi of 14C-AAI101 + 500 mg AAI101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 µCi of 14C-AAI101 + 500 mg AAI101Drug
Also called 14C-AAI101 + 500 mg AAI101 iv infusion
Single dose open label
| Study group | Role | What they receive |
|---|---|---|
| 1 µCi of 14C-AAI101 + 500 mg AAI101 | Experimental | 14C-AAI101 + 500 mg AAI101 iv infusion Receives: Drug: 1 µCi of 14C-AAI101 + 500 mg AAI101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of total radiolabelled 14C-content in blood, plasma, urine, and feces.
Measured: Up to 7 days post dosing
Concentration of parent AAI101 in plasma and urine.
Measured: 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.
Measured: 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.
Measured: Up to 7 days post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start27 Nov 2018
- Primary completion5 Dec 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allecra
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775668
- Sponsor's protocol ID
- AT-104
- Status last verified
- Dec 2018
- First submitted
- 12 Dec 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03775668
- Acronym / sponsor ID
- AT-104
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AllecraIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 5 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 µCi of 14C-AAI101 + 500 mg AAI101 | Experimental | Drug: 1 µCi of 14C-AAI101 + 500 mg AAI10114C-AAI101 + 500 mg AAI101 iv infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 µCi of 14C-AAI101 + 500 mg AAI101Also: 14C-AAI101 + 500 mg AAI101 iv infusionSingle dose open label | Drug | 1 µCi of 14C-AAI101 + 500 mg AAI101 |
Primary outcome
Concentrations of total radiolabelled 14C-content in blood, plasma, urine, and feces.
Time frame: Up to 7 days post dosing
Concentration of parent AAI101 in plasma and urine.
Time frame: Up to 7 days post dosing
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1 µCi of 14C-AAI101 + 500 mg AAI101 in people with Healthy, run by Allecra at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrations of total radiolabelled 14C-content in blood, plasma, urine, and feces. (time frame: Up to 7 days post dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.