Bioavailability of ATI-1501 With Taste Test Sub Study

NCT03337126 | Completed Phase 1 FDA Drug

• 1 other identifier: ATI-1501-02
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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 Bioequivalent.

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (1)

• Relative bioavailability

  Relative bioavailability of ATI-1501 compared to Flagyl® tablets under fasting and fed conditions

  48 hours

Secondary Outcomes (1)

• Palatability

  4 hours

Study Arms (2)

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

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

Drug: Metronidazole Tablet

Interventions

Metronidazole Tablet DRUG

Comparator Drug

Also known as: Flagyl

Fasting Condition; Fed Condition

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Appili Therapeutics Inc.: lead
• Syneos Health: collaborator

Study Sites (1)

INC Research Inc.

Toronto, Ontario, M5V2T3, Canada

Location

MeSH Terms

Interventions

Metronidazole

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Michael McDonnell, MD

  Syneos Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomized, Open-Label, Single Dose, Two Sequence, Crossover

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 8, 2017
• Study Start: November 6, 2017
• Primary Completion: December 13, 2017
• Study Completion: December 30, 2017
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

CA (1)