- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03337126
Bioavailability of ATI-1501 With Taste Test Sub Study
January 10, 2019 updated by: Appili Therapeutics Inc.
A Phase 1, Randomized, Open-Label, Single Dose, Two Sequence, Crossover, Relative Bioavailability and Taste Test Study of ATI-1501 in Healthy Adult Volunteers
Appili Therapeutics Inc. is developing an oral suspension formulation of metronidazole (ATI-1501), a taste-masked reformulation of metronidazole.
The purpose of this study is to compare the relative bioavailability of ATI-1501 with the Reference Listed Drug (RLD) in healthy, adult volunteers to determine that it is Bioequivalent.
Study Overview
Detailed Description
This is a Phase 1, single-center, randomized, open-label, single dose, 2 sequence, 2 treatment, crossover, relative bioavailability study of ATI-1501 under fasting and fed conditions in healthy adult subjects.
The purpose of this study is to determine the relative bioavailability of ATI-1501 oral suspension to the comparator drug, Flagyl®.
The study also aims to evaluate the safety and characterize the PK profile of ATI-1501 oral suspension in healthy adults.
The PK of ATI-1501 oral suspension in a population of subjects with no concomitant illnesses will be recorded and analyzed.
Blood samples will be collected through individual venipuncture or an indwelling catheter at pre-described time intervals throughout the study to determine the bioavailability of ATI-1501 oral suspension and characterize its overall PK profile.
In addition, blood samples will also be collected using a microsampling device to validate the use of blood microsampling for future studies.
Subjects will be randomized to 1 of 2 treatment sequences and each group of subjects will undergo 4 periods of treatment.
Each subject will receive each treatment regimen in this crossover study design, allowing for a 7-day washout period.
The study drugs will be administered under fasting and fed conditions to evaluate the effects of food on the absorption of metronidazole, administered in the ATI-1501 oral suspension.
The palatability of ATI-1501 will be assessed using the 9-point scale to assess the taste, texture, and smell of the 2 study drugs.
A 3-point scale will be used to evaluate the degree of bitterness of the 2 study drugs
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5V2T3
- INC Research Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male or female subjects 18 to 65 years of age, inclusive.
- Body mass index (BMI) within the range of 18.0 to 30.0 kg/m2, inclusive, and a minimum weight of 50.0 kg.
- Continuous non-smoker for at least 3 months prior to screening and tests negative on urine cotinine confirmatory test.
- Female subjects of childbearing potential with male sexual partners must be using and willing to continue using medically acceptable contraception for at least 1 month prior to screening (at least 3 months for oral and transdermal contraceptives) and for at least 1 month after the last study drug administration.
- Female subjects of non-childbearing potential
- Male subjects with female sexual partners of childbearing potential must be using and willing to continue using medically acceptable contraception from screening and for at least 1 month after the last study drug administration.
- Able to speak, read, and understand English sufficiently to allow completion of all study assessments.
- Must provide written informed consent prior to the initiation of any protocol-specific procedures.
Exclusion Criteria:
- History or presence of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, such as evidence of gastrointestinal (GI), hepatic or renal disease that may affect absorption, distribution, metabolism, or excretion of the orally administered study drug.
- Recent history (within 4 weeks prior to screening) or current active infection associated with fever and/ or requiring antibiotic therapy.
- Presence of latent or chronic infection (eg, recurrent sinusitis, urinary tract infection, genital or ocular herpes).
- Any medical/surgical procedure or trauma within 4 weeks of the first study drug administration.
- Any malignancy within the previous 5 years, with the exception of superficial skin cancer treated with local therapy.
- Self-reported history of substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years, and/or has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence.
- Self-reported family history of substance abuse in an immediate family member (eg, parent, sibling or child).
- Positive urine drug screen.
- Positive breath alcohol test.
- History or presence of clinically significant abnormality as assessed by physical examination, medical history, ECGs, vital signs, or laboratory values, which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
- Evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 x upper limit of normal (ULN), or bilirubin >1 x ULN.
- Inability to fast for a minimum of 14 hours.
- Positive for hepatitis A, hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or tuberculosis.
- Donation or loss of more than 500 mL whole blood within 30 days preceding entry into the Treatment phase.
- Plasma donation within 7 days prior to dosing of study drug.
- Difficulty with venous access or unsuitable or unwilling to undergo catheter insertion.
- Female subjects who are currently pregnant (have a positive pregnancy test) or lactating or who are planning to become pregnant within 30 days of last study drug administration.
- History of severe allergic reaction (including anaphylaxis) to any substance, or previous status asthmaticus.
- History of allergy or hypersensitivity to Flagyl®, ATI-1501, or other nitroimidazole derivatives.
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected to during the conduct of the study.
- Use of a prohibited medication, as specified in Section 4.4.1.
- Treatment with an investigational drug within 30 days (if the elimination half-life is unknown) prior to first drug administration or is concurrently enrolled in any research judged not to be scientifically or medically compatible with this study.
- An employee of the sponsor or research site personnel directly affiliated with this study or their immediate family member defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- A subject who, in the opinion of the investigator or designee, is considered unsuitable or unlikely to comply with the study protocol for any reason.
- A subject who has pending legal charges or is on probation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Fasting Condition
Single dose of ATI-1501(oral suspension) administered under fasting conditions; BioAvailability and PK parameters will be measured and analyzed.
These parameters will be compared to the BA and PK parameters measured after administration of a single Metronidazole Tablet
|
Comparator Drug
Other Names:
|
Active Comparator: Fed Condition
Single dose of ATI-1501(oral suspension) administered under fed condition; BioAvailability and PK parameters will be measured and analyzed.
These parameters will be compared to the BA and PK parameters measured after administration of a single Metronidazole Tablet
|
Comparator Drug
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative bioavailability
Time Frame: 48 hours
|
Relative bioavailability of ATI-1501 compared to Flagyl® tablets under fasting and fed conditions
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Palatability
Time Frame: 4 hours
|
Palatability of ATI-1501
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 6, 2017
Primary Completion (Actual)
December 13, 2017
Study Completion (Actual)
December 30, 2017
Study Registration Dates
First Submitted
November 6, 2017
First Submitted That Met QC Criteria
November 6, 2017
First Posted (Actual)
November 8, 2017
Study Record Updates
Last Update Posted (Actual)
January 11, 2019
Last Update Submitted That Met QC Criteria
January 10, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATI-1501-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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