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Drug Drug InteractionPhase 1NCT05137600

A Drug-Drug Interaction Study Between ATI-2173 and Midazolam or Clarithromycin in Healthy Subjects

A Phase 1 study testing ATI-2173, Midazolam and Clarithromycin in people with Drug Drug Interaction, run by Antios Therapeutics, Inc at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a single-center, open-label, 2-cohort, fixed-sequence, DDI study in healthy adult subjects. Healthy volunteers will be administered multiple oral doses of ATI-2173 in combination with midazolam or clarithromycin and assessed for safety and tolerability including blood tests to show how the body… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Drug Drug Interaction
What is being tested?
ATI-2173, Midazolam and Clarithromycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteCanada
Study dates
28 Oct 2021to 23 Jan 2022
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Provision of signed and dated Informed Consent Form (ICF)
  • Stated willingness to comply with all study procedures (including ability and willingness to abstain from alcohol from 48 hours prior to the first study drug administration until discharge) and availability for the duration of the study
  • Healthy adult male or female
  • Aged between 18 and 60 years, inclusive
  • Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively
  • Non- or ex-smoker (an ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration)
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  • Suitable veins for cannulation or repeated venipuncture as assessed by an Investigator at Screening
  • If female, meets one of the following criteria:
  • Is of childbearing potential and agrees to use an acceptable contraceptive method. Acceptable contraceptive methods include
  • Abstinence from heterosexual intercourse from the first study drug administration through to at least 60 days after the last dose of the study drug
  • Non-hormonal intrauterine device (IUD) with a barrier method (eg, male condom) used from at least 28 days prior to the first study drug administration through to at least 60 days after the last dose of the study drug
  • Double-barrier method (eg, male condom, spermicide and diaphragm or cervical cap used simultaneously )from Screening through to at least 60 days after the last dose of the study drug
  • Male partner vasectomized at least 6 months prior to Screening Or
  • Is of non-childbearing potential, defined as surgically sterile (ie, has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a postmenopausal state (ie, at least 1 year without menses without an alternative medical condition prior to the first study drug administration), as confirmed by follicle-stimulating hormone levels (≥ 40 mIU/mL).
  • If male, meets one of the following criteria:
  • Is able to procreate and agrees to use one of the accepted contraceptive regimens and not to donate sperm from the first study drug administration to at least 90 days after the last drug administration. An acceptable method of contraception includes one of the following:
  • Abstinence from heterosexual intercourse
  • Male condom with spermicide or male condom with a vaginal spermicide (gel, foam, or suppository) Or
  • Is unable to procreate; defined as surgically sterile (ie, has undergone a vasectomy at least 6 months prior to Screening)
  • Agrees to abstain from blood or plasma donation from the Screening visit until 3 months after the last study drug administration
  • Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination, vital signs, myopathy questionnaire, and/or ECG, as determined by an Investigator Cohort 1 only
  • Have no clinically significant findings on the neurological examination and/or oxygen saturation measurement as determined by an Investigator

Who cannot join

  • Female who is lactating
  • Female who is pregnant according to the pregnancy test at Screening or prior to the first study drug administration
  • Female using the following systemic contraceptives: oral, patch or vaginal ring, in the 28 days prior to the first study drug administration
  • Female using hormone replacement therapy in the 28 days prior to the first study drug administration
  • Female using the following systemic contraceptives: injections or implant, or hormone-releasing IUD in the 13 weeks prior to the first study drug administration
  • Seated pulse rate less than 50 beats per minute or more than 100 beats per minute at Screening or prior to the first study drug administration
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  • Seated blood pressure below 105/60 mmHg or higher than 140/90 mmHg at Screening or prior to the first study drug administration
  • Estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73m2, calculated using the Modification of Diet in Renal Disease (MDRD) equation, at Screening or prior to the first study drug administration
  • Presence of out-of-range cardiac interval (PR < 110 msec, PR > 200 msec, QRS < 60 msec, QRS >110 msec and QTcF > 440 msec) on the ECG at Screening or at Check-in or other clinically significant ECG abnormalities, unless deemed non-significant by an Investigator
  • Hemoglobin value below the lower limit of the reference laboratory at Screening or prior to study drug administration
  • Any other clinically significant abnormalities in laboratory test results at Screening. Subjects with alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), creatine kinase (CK) or total bilirubin outside the normal range at Screening or Day -1 will be excluded.
  • Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first drug administration
  • Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus antibody tests at Screening
  • Positive screening results to SARS-CoV-2 virus tests prior to the first study drug administration
  • History of significant hypersensitivity to ATI-2173, clevudine, midazolam, clarithromycin, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
  • Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
  • History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
  • Presence of clinically significant muscle disorders, myopathies or other forms of liver disease
  • Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
  • Any clinically significant illness in the 28 days prior to the first study drug administration
  • Use of any prescription drugs (including hormonal contraceptives and hormone replacement therapy) or any CYP3A inhibitors, inducers, or substrates in the 30 days prior to the first study drug administration, that in the opinion of an Investigator would put into question the status of the participant as healthy
  • Use of St. John's wort in the 30 days prior to the first study drug administration
  • Use of over-the-counter (OTC) medications, herbal supplements, and vitamins in the 14 days prior to the first study treatment administration.
  • Use of quinine-containing products (eg, tonic water), grapefruit products, pomelo products, Seville orange products, including supplements containing Citrus aurantium or "bitter orange", in the 14 days prior to the first study drug administration
  • Consumption of food or beverages containing xanthines (ie, tea, coffee, cola drinks, energy drinks or chocolate) in the 48 hours prior to the first study drug administration
  • Any history of tuberculosis
  • Immunization with a coronaviruse disease 2019 (COVID-19) vaccine in the 14 days prior to the first study drug administration
  • Scheduled immunization with a COVID-19 vaccine (first or second dose) during the study that, in the opinion of an Investigator, could potentially interfere with subject participation, subject safety, study results, or any other reason
  • Inclusion in a previous group for this clinical study
  • Participation in another clinical study with a non-biologic investigational product (IP) or new formulation of a marketed non-biologic drug in the 30 days prior to Screening
  • Participation in another clinical study with any marketed or investigational biologic product within 90 days or 5 half-lives, whichever is longer, prior to Screening
  • Donation of 50 mL or more of blood in the 28 days prior to the first study drug administration
  • Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first study drug administration Cohort 1
  • Oxygen saturation (SpO2) below 95% at Screening or prior to the first study drug administration
  • Family history of sudden cardiac death or known prolonged QTc

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Altasciences

    Montreal, Quebec, H3P 3P1

Other trials in Canada

About this study

Official title: A Phase 1, Open-label, 2-cohort, Fixed-sequence, Drug-drug Interaction Study to Investigate the Potential Interaction Between ATI-2173 When Coadministered With Midazolam or Clarithromycin in Healthy Subjects

This study is a single-center, open-label, 2-cohort, fixed-sequence, DDI study in healthy adult subjects. Healthy volunteers will be administered multiple oral doses of ATI-2173 in combination with midazolam or clarithromycin and assessed for safety and tolerability including blood tests to show how the body metabolizes and eliminates the investigational drug as well as how the investigational drug interacts with midazolam or clarithromycin.

Being tested
ATI-2173, Midazolam, Clarithromycin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATI-2173Drug

    ATI-2173 is a liver-targeted phosphoramidate prodrug of clevudine designed to enhance anti-HBV activity while decreasing systemic exposure to clevudine. It will be dosed as a capsule by mouth

  • MidazolamDrug

    Midazolam is a sensitive CYP3A index substrate

  • ClarithromycinDrug

    Clarithromycin is a sensitive P-gp index inhibitor to evaluate potential effect of P-gp inhibition on ATI-2173 and its metabolites(clarithromycin)

Study groups in NCT05137600
Study groupRoleWhat they receive
ATI-2173 50 mgExperimentalATI-2173 is a liver-targeted phosphoramidate prodrug of clevudine designed to enhance anti-HBV activity while decreasing systemic exposure to clevudine. It will be dosed as a capsule by mouth
Receives: Drug: ATI-2173
MidazolamExperimentalMidazolam is a sensitive CYP3A index substrate
Receives: Drug: Midazolam
ClarithromycinExperimentalClarithromycin is a sensitive P-gp index inhibitor to evaluate potential effect of P-gp inhibition on ATI-2173 and its metabolites
Receives: Drug: Clarithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax of Midazolam

    Measured: Through end of study, approximately 3 months

  2. AUC0-t of Midazolam

    Measured: Through end of study, approximately 3 months

  3. AUC0-inf of Midazolam

    Measured: Through end of study, approximately 3 months

  4. Cmax of ATI-2173

    Measured: Through end of study, approximately 3 months

  5. AUCtau of ATI-2173

    Measured: Through end of study, approximately 3 months

  6. AUC0-t of ATI-2173

    Measured: Through end of study, approximately 3 months

  7. AUCo-inf of ATI-2173

    Measured: Through end of study, approximately 3 months

Secondary outcomes (1)

  1. Number of adverse events

    Measured: Through end of study, approximately 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2021
  2. Study start28 Oct 2021
  3. Primary completion23 Dec 2021
  4. Study completion23 Jan 2022

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05137600
Sponsor's protocol ID
ANTT103
Status last verified
Feb 2022
First submitted
28 Oct 2021
Last updated
4 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ATI-2173, Midazolam and Clarithromycin in people with Drug Drug Interaction, run by Antios 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 22 inclusion and 35 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 4 Feb 2022. 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?

Cmax of Midazolam (time frame: Through end of study, approximately 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05137600.

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 4 Feb 2022.

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