BioequivalencePhase 1NCT03337126
Bioavailability of ATI-1501 With Taste Test Sub Study
A Phase 1 study testing Metronidazole Tablet in people with Bioequivalence, run by Appili Therapeutics Inc. at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Metronidazole Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 6 Nov 2017to 30 Dec 2017
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Bioequivalence
- Being tested
- Metronidazole Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole TabletDrug
Also called Flagyl
Comparator Drug
| Study group | Role | What they receive |
|---|---|---|
| Fasting Condition | Active comparator | 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 Receives: Drug: Metronidazole Tablet |
| Fed Condition | Active comparator | 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 Receives: Drug: Metronidazole Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability
Relative bioavailability of ATI-1501 compared to Flagyl® tablets under fasting and fed conditions
Measured: 48 hours
Secondary outcomes (1)
Palatability
Palatability of ATI-1501
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start6 Nov 2017
- Primary completion13 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, Open-Label, Single Dose, Two Sequence, Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Appili Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Michael McDonnell, MD, Principal investigator, Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337126
- Sponsor's protocol ID
- ATI-1501-02
- Status last verified
- Jan 2019
- First submitted
- 6 Nov 2017
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Single Dose, Two Sequence, Crossover, Relative Bioavailability and Taste Test Study of ATI-1501 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03337126
- Acronym / sponsor ID
- ATI-1501-02
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Appili Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 8 Nov 2017 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Open-Label, Single Dose, Two Sequence, Crossover
| Arm | Type | Receives |
|---|---|---|
| Fasting Condition | Active comparator | Drug: Metronidazole TabletSingle 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 |
| Fed Condition | Active comparator | Drug: Metronidazole TabletSingle 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (25 listed)
- 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.
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 |
|---|---|---|
| Metronidazole TabletAlso: FlagylComparator Drug | Drug | Fasting Condition, Fed Condition |
Primary outcome
Relative bioavailability
Time frame: 48 hours
Relative bioavailability of ATI-1501 compared to Flagyl® tablets under fasting and fed conditions
1 secondary outcome
Palatability
Time frame: 4 hours
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 11 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
Michael McDonnell, MD principal investigator
Syneos Health
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 Metronidazole Tablet in people with Bioequivalence, run by Appili Therapeutics Inc. at 1 site in Canada.
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 8 inclusion and 25 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 11 Jan 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 Canada. 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?
Relative bioavailability (time frame: 48 hours). 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 11 Jan 2019.