Healthy VolunteerPhase 1NCT06911242
A Comparison of the Pharmacokinetic Properties of ARN-75039 Tablets With Excipients to Neat ARN-75039 in Hydroxypropyl Methylcellulose (HPMC) Capsules in Healthy Adult Participants Under Fed Conditions
A Phase 1 study testing ARN-75039 in people with Healthy Volunteer and Pharmacokinetics After Oral Intake, run by Arisan Therapeutics, Inc. at 1 site in United States.
Trial summary
ARN-75039-103 is a comparative, randomized, single-dose, cross-over study to assess the PK, safety, and tolerability of neat ARN-75039 in hydroxypropyl methylcellulose (HPMC) capsules compared with ARN-75039 with excipients in tablet form, both administered orally, in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Pharmacokinetics After Oral Intake
- What is being tested?
- ARN-75039
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2025to 21 Apr 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants meeting all the following criteria are eligible for study participation:
- Is male or female, age 18 to 45 years, inclusive, at Screening.
- Body mass index (BMI) between 18 and 35 kg/m2, inclusive, at Screening.
- In good general health, determined by no clinically significant findings in the opinion of the Investigator from medical history, physical examination, 12-lead ECG, clinical laboratory findings, and vital signs at Screening and Day -1 or 1.
- Hemoglobin, hematocrit, white blood cell count, absolute neutrophil count, and platelet count results within the laboratory reference range at Screening or without clinically significant abnormalities in the opinion of the Investigator; participants with Gilbert's disease with associated abnormalities of liver function tests are eligible for enrollment. Tests may be repeated at the discretion of the Investigator to confirm abnormalities.
- Estimated glomerular filtration rate (eGFR) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of ≥ 80 mL/min/1.73 m2 at Screening.
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- Females of childbearing potential must practice effective contraception per national regulatory guidelines for clinical trials from Screening (see Section 5.6.2), throughout the study, and for 60 days after the last dose of study drug.
- Females must have a negative pregnancy test at Screening and within 24 hours prior to dosing of study drug; for post-menopausal participants, a blood sample will also be tested for estradiol and follicle stimulating hormone (FSH) to confirm post-menopausal status based on reference laboratory ranges for post-menopausal status. Surgically sterile females are eligible; however, proof via medical records will be required.
- Males must agree to not donate sperm and to use condom and spermicide in combination with any of the means of contraception for their female partners during sexual intercourse from the time of the first study drug administration and for 90 days following the last dose of study drug. Females must agree not to donate eggs from the time of the first study drug administration and for 60 days following the last dose of study drug.
- Must be willing and able to comply with measures to avoid photosensitivity reactions (i.e., avoidance of outdoor sun exposure and tanning; consistent use of long sleeve shirts, long pants, hats, and sunglasses; consistent use of sun protection factor [SPF] 75 or greater sunscreen when outdoors) during the study treatment period.
- Able to consume a standard meal (400-600 Calories) within 30 minutes.
- Able to provide informed consent.
- Willing and able to comply with this protocol and be available for the entire duration of the study.
Who cannot join
- Participants meeting any of the following criteria are not eligible for study participation:
- Any clinically significant underlying illness in the opinion of the Investigator.
- Poor venous access.
- Prior exposure to ARN-75039.
- History of drug or alcohol abuse within 1 year of Screening in the opinion of the investigator, or a positive test for drugs of abuse or alcohol at Screening or Day -1.
- Use of any prescription or over-the-counter (OTC) medications, including food supplements, vitamins, herbal medications (e.g., St. John's wort), and cannabis, with the exception of contraceptive medications and as needed (prn) acetaminophen or paracetamol (not exceeding 2 grams/day) within 7 days prior to study drug administration and through the Day 15 Discharge visit.
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- Any female who is pregnant or breastfeeding, or any female who is planning to become pregnant during the study and safety follow-up period.
- Currently enrolled in another investigational device or drug study, or less than 30 days or 5 half-lives of the prior investigational agent (whichever is longer) or plans to enroll in another investigational device or drug study during the course of this study.
- Inability to ingest all capsules/tablets of a multi-capsule dose within 5 minutes of ingestion of the first capsule/tablet.
- Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) at Screening; participants with adequately treated HCV are eligible for enrollment.
- Consumption of Seville oranges, grapefruit or grapefruit juice within 72 hours prior to Day 1 or during the study.
- History of malignancy, except adequately treated basal cell carcinoma or in situ carcinoma of the uterine cervix.
- Smoking cigarettes, cigars, cigarillos or E-cigarettes
- Any reason or condition that, in the investigator's opinion, may compromise study participation, present a safety risk to the participant, or may confound the interpretation of the study results.
- A QT duration corrected for heart rate by Fridericia's formula (QTcF) > 450 millisecond (msec) based on either single or averaged QTcF values of triplicate ECGs obtained over a 3-minute interval (at Screening).
- Blood product (including plasma) donation within 30 days before Screening.
- Unwilling to consume a breakfast on study drug administration days.
- History of:
- Structural abnormality of the GI tract or a disease or history of a condition that can affect GI motility.
- Inflammatory bowel disease (even if treated and currently in remission).
- Diverticulitis or any other chronic condition such as chronic pancreatitis, polycystic kidney disease, ovarian cysts, endometriosis, lactose intolerance that can be associated with abdominal pain or discomfort and could confound the assessments in this trial.
- Chronic idiopathic diarrhea.
- Formally diagnosed colonic inertia or conditions that can be associated with constipation: pseudo-obstruction, colonic inertia, megacolon, megarectum, bowel obstruction, descending perineum syndrome, solitary rectal ulcer syndrome, systemic sclerosis, lower tract evacuation disorders, functional outlet delay (e.g., rectal prolapse, anismus, etc.).
- Current active peptic ulcer disease (i.e., disease that is not adequately treated or stable with therapy.)
- Potential central nervous system cause of constipation (e.g., Parkinson's disease, spinal cord injury, and multiple sclerosis).
- Participant currently has both unexplained and clinically significant alarm symptoms (lower GI bleeding [rectal bleeding or heme-positive stool], iron-deficiency anemia or any unexplained anemia, or weight loss) or systemic signs of infection or colitis.
- History of chronic/generalized pruritus and/or skin rash of unknown origins.
- Participants with diagnosed Type 1 or Type 2 diabetes, or with a fasting blood glucose value > 125 mg/dL during the screening period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative, Randomized, Two-Period, Crossover Study to Compare Pharmacokinetic Properties of ARN-75039 Tablets With Excipients to Neat ARN-75039 in Hydroxypropyl Methylcellulose (HPMC) Capsules in Healthy Adult Participants Under Fed Conditions
ARN-75039-103 is a comparative, randomized, single-dose, cross-over study to assess the PK, safety, and tolerability of neat ARN-75039 in hydroxypropyl methylcellulose (HPMC) capsules compared with ARN-75039 with excipients in tablet form, both administered orally, in healthy adult participants. The safety assessments will include standard evaluations of vital signs, clinical laboratory values, and ECGs.
Participants will be admitted to the study site on the morning of Day -1, before Period 1 study drug administration, and will remain on site until Day 15. Upon confirmation of eligibility, participants will be randomized into the study on Day 1. Study drug administration will be performed on the first day of Periods 1 and 2 (Study Days 1 and 8, respectively) with a 7-day washout period between the two periods. Participants will receive the randomized study drug in the morning following a meal. A total of 16 participants will be randomized 1:1 to the following two sequences:
Read more
- Sequence 1:
- Form A: Neat ARN-75039 in HPMC capsules (reference product)
- Form B: ARN-75039 with excipients in tablet form (comparator)
- Sequence 2:
- Form B: ARN-75039 with excipients in tablet form (comparator)
- Form A: Neat ARN-75039 in HPMC capsules (reference product)
Participation in the study will be conducted in the following 5 defined periods:
- Screening Period: The Screening Period begins upon completion of the informed consent form (ICF). During this period, participants will undergo baseline assessments to determine eligibility for study participation. The Screening Period duration will be up to 21 days; it will end after all evaluations required to meet eligibility have been completed. If a participant meets all eligibility criteria, they will be offered enrollment into the study.
- Admission to Study Site: Participants will be admitted to the study site in the morning on the day before dosing of period 1 (Day -1). Participants who are eligible to participate in the study and are randomized into the study will remain at the study site until completion of the treatment period (Study Day 15).
- Treatment Period: This study consists of two treatment days separated by a 7-day washout period. The first treatment day will begin on Day 1 of Period 1 with administration of the first dose of study drug. The second treatment day will occur on the first day of Period 2 (Study Day 8). Following the dosing of the study drug on each treatment day, fifteen venous blood samples will be withdrawn via an indwelling cannula or by venipuncture at regular time intervals.
- End of Active Treatment (Day 15 Discharge Visit or Early Termination (ET) Visit): Upon successful completion of active treatment, participants will be discharged from the study site on Study Day 15. The Discharge Visit will include the completion of safety assessments, such as a physical examination, vitals, ECG recording, adverse event review, and clinical laboratory tests. Participants who complete both dosing days will be encouraged to complete all study visits.
Participants who do not complete all study visits or terminate from the study before Day 15 will be asked to complete The Early Termination Visit is within 1 day after withdrawal from the study.
- Day 36 Telephone Follow-Up Phone Call: Participants will be contacted by phone on Day 36-i.e., 28 days following the last study dose administered on Day 8. The purpose of this follow-up call is to assess for any adverse events.
Read the detailed description
Two-period cross-over, Form A vs Form B, fed, inpatient Day -1 through Day 15, Day 36 follow-up
- Being tested
- ARN-75039
- Keywords
- Pharmacokinetics, Relative Bioavailability, Crossover, ARN-75039, HPMC capsule, Tablet With Excipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARN-75039Drug
An oral therapy for the treatment of Lassa infection
| Study group | Role | What they receive |
|---|---|---|
| Form A | Experimental | Investigational antiviral agent (300 mg neat ARN-75039 in HPMC capsules) administered as a single oral dose for pharmacokinetic evaluation. Receives: Drug: ARN-75039 |
| Form B | Experimental | Investigational antiviral agent (3x100 mg ARN-75039 tablet with excipients) administered as a single oral dose for pharmacokinetic evaluation. Receives: Drug: ARN-75039 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
Area Under the Plasma-drug Concentration Time Curve from time zero to time of last quantifiable concentration. Compare the pharmacokinetic (PK) properties of 300mg ARN-75039 with excipients in tablet form to 300mg neat ARN-75039 in HPMC capsules following oral administration under fed conditions.
Measured: From time zero (dose) to time of last quantifiable concentration. Period 1: 0 to 144 hours; Period 2: 0 to 168 hours.
AUC0-24
Area under the plasma concentration-time curve from time zero to 24 hours post-dose. Compare the pharmacokinetic (PK) properties of 300mg ARN-75039 with excipients in tablet form to 300mg neat ARN-75039 in HPMC capsules following oral administration under fed conditions.
Measured: From time zero (dose) to 24 hours post-dose.
AUC0-∞
Area under plasma concentration-time curve from time zero to infinity. Compare the pharmacokinetic (PK) properties of 300mg ARN-75039 with excipients in tablet form to 300mg neat ARN-75039 in HPMC capsules following oral administration under fed conditions.
Measured: From time zero (dose) extrapolated to infinity. Time frame is from 0 to Tlast + extrapolation from C last to infinity time, where concentration is equal to 0.
Cmax
Maximum observed plasma concentration. Compare the pharmacokinetic (PK) properties of 300mg ARN-75039 with excipients in tablet form to 300mg neat ARN-75039 in HPMC capsules following oral administration under fed conditions.
Measured: From time 0 (dose) through 168 hours post-dose.
Tmax
Time to reach Cmax
Measured: From time 0 (dose) through 168 hours post-dose.
t1/2
Half-life
Measured: From time 0 (dose) through 168 hours post-dose (terminal elimination phase).
CL/F
Apparent clearance after extravascular administration.
Measured: From time 0 (dose) through 168 hours post-dose (derived from the concentration-time profile).
Vz/F
Apparent volume of distribution during the terminal phase after extravascular administration.
Measured: From time 0 (dose) through 168 hours post-dose (derived from the concentration-time profile).
Secondary outcomes (3)
Participants With ≥1 TEAE
Type and frequency of treatment-emergent adverse events (TEAEs).
Measured: From first dose through approximately 7 days after the last dose (includes washout); with Day 36 follow-up phone call to assess for any adverse events (AEs).
Participants With ≥1 TESAE
Type and frequency of treatment-emergent serious adverse events (TESAEs).
Measured: From first dose through approximately 7 days after the last dose (includes washout); with Day 36 follow-up phone call to assess for any adverse events (AEs).
Participants With Study Drug-related TEAEs of Grade >1
Type and frequency of study drug-related >Grade 1 TEAEs
Measured: From first dose through approximately 7 days after the last dose (includes washout); with Day 36 follow-up phone call to assess for any adverse events (AEs).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start27 Feb 2025
- Primary completion21 Apr 2025
- Study completion21 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteerStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study used a 2-period, 2-sequence crossover design (Sequence 1: A→B; Sequence 2: B→A). All 16 randomized participants completed both periods and contributed data to both formulations. Participant numbers per arm in the results represent treatment at the time of measurement, not unique participants.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arisan Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ken McCormack, PhD, Study chair, Arisan Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911242
- Sponsor's protocol ID
- ARN-75039-103
- Status last verified
- Jan 2026
- First submitted
- 13 Mar 2025
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Randomized, Two-Period, Crossover Study to Compare Pharmacokinetic Properties of ARN-75039 Tablets With Excipients to Neat ARN-75039 in Hydroxypropyl Methylcellulose (HPMC) Capsules in Healthy Adult Participants Under Fed Conditions
- ClinicalTrials.gov ID
- NCT06911242
- Acronym / sponsor ID
- ARN-75039-103
- Keywords
- Pharmacokinetics, Relative Bioavailability, Crossover, ARN-75039, HPMC capsule, Tablet With Excipients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Arisan Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 21 Apr 2025 (actual)
- Study completion
- 21 Apr 2025 (actual)
- First posted
- 4 Apr 2025 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ARN-75039-103 is a comparative, randomized, single-dose, cross-over study to assess the PK, safety, and tolerability of neat ARN-75039 in hydroxypropyl methylcellulose (HPMC) capsules compared with ARN-75039 with excipients in tablet form, both administered orally, in healthy adult participants. The safety assessments will include standard evaluations of vital signs, clinical laboratory values, and ECGs.
Participants will be admitted to the study site on the morning of Day -1, before Period 1 study drug administration, and will remain on site until Day 15. Upon confirmation of eligibility, participants will be randomized into the study on Day 1. Study drug administration will be performed on the first day of Periods 1 and 2 (Study Days 1 and 8, respectively) with a 7-day washout period between the two periods. Participants will receive the randomized study drug in the morning following a meal. A total of 16 participants will be randomized 1:1 to the following two sequences:
- Sequence 1:
- Form A: Neat ARN-75039 in HPMC capsules (reference product)
- Form B: ARN-75039 with excipients in tablet form (comparator)
- Sequence 2:
- Form B: ARN-75039 with excipients in tablet form (comparator)
- Form A: Neat ARN-75039 in HPMC capsules (reference product)
Participation in the study will be conducted in the following 5 defined periods:
- Screening Period: The Screening Period begins upon completion of the informed consent form (ICF). During this period, participants will undergo baseline assessments to determine eligibility for study participation. The Screening Period duration will be up to 21 days; it will end after all evaluations required to meet eligibility have been completed. If a participant meets all eligibility criteria, they will be offered enrollment into the study.
- Admission to Study Site: Participants will be admitted to the study site in the morning on the day before dosing of period 1 (Day -1). Participants who are eligible to participate in the study and are randomized into the study will remain at the study site until completion of the treatment period (Study Day 15).
- Treatment Period: This study consists of two treatment days separated by a 7-day washout period. The first treatment day will begin on Day 1 of Period 1 with administration of the first dose of study drug. The second treatment day will occur on the first day of Period 2 (Study Day 8). Following the dosing of the study drug on each treatment day, fifteen venous blood samples will be withdrawn via an indwelling cannula or by venipuncture at regular time intervals.
- End of Active Treatment (Day 15 Discharge Visit or Early Termination (ET) Visit): Upon successful completion of active treatment, participants will be discharged from the study site on Study Day 15. The Discharge Visit will include the completion of safety assessments, such as a physical examination, vitals, ECG recording, adverse event review, and clinical laboratory tests. Participants who complete both dosing days will be encouraged to complete all study visits.
Participants who do not complete all study visits or terminate from the study before Day 15 will be asked to complete The Early Termination Visit is within 1 day after withdrawal from the study.
- Day 36 Telephone Follow-Up Phone Call: Participants will be contacted by phone on Day 36-i.e., 28 days following the last study dose administered on Day 8. The purpose of this follow-up call is to assess for any adverse events.
Detailed description
Two-period cross-over, Form A vs Form B, fed, inpatient Day -1 through Day 15, Day 36 follow-up
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study used a 2-period, 2-sequence crossover design (Sequence 1: A→B; Sequence 2: B→A). All 16 randomized participants completed both periods and contributed data to both formulations. Participant numbers per arm in the results represent treatment at the time of measurement, not unique participants.
| Arm | Type | Receives |
|---|---|---|
| Form A | Experimental | Drug: ARN-75039Investigational antiviral agent (300 mg neat ARN-75039 in HPMC capsules) administered as a single oral dose for pharmacokinetic evaluation. |
| Form B | Experimental | Drug: ARN-75039Investigational antiviral agent (3x100 mg ARN-75039 tablet with excipients) administered as a single oral dose for pharmacokinetic evaluation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Is male or female, age 18 to 45 years, inclusive, at Screening.
- Body mass index (BMI) between 18 and 35 kg/m2, inclusive, at Screening.
- In good general health, determined by no clinically significant findings in the opinion of the Investigator from medical history, physical examination, 12-lead ECG, clinical laboratory findings, and vital signs at Screening and Day -1 or 1.
- Hemoglobin, hematocrit, white blood cell count, absolute neutrophil count, and platelet count results within the laboratory reference range at Screening or without clinically significant abnormalities in the opinion of the Investigator; participants with Gilbert's disease with associated abnormalities of liver function tests are eligible for enrollment. Tests may be repeated at the discretion of the Investigator to confirm abnormalities.
- Estimated glomerular filtration rate (eGFR) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of ≥ 80 mL/min/1.73 m2 at Screening.
Key exclusion criteria (28 listed)
- Participants meeting any of the following criteria are not eligible for study participation:
- Any clinically significant underlying illness in the opinion of the Investigator.
- Poor venous access.
- Prior exposure to ARN-75039.
- History of drug or alcohol abuse within 1 year of Screening in the opinion of the investigator, or a positive test for drugs of abuse or alcohol at Screening or Day -1.
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 |
|---|---|---|
| ARN-75039An oral therapy for the treatment of Lassa infection | Drug | Form A, Form B |
Primary outcome
AUC0-t
Time frame: From time zero (dose) to time of last quantifiable concentration. Period 1: 0 to 144 hours; Period 2: 0 to 168 hours.
Area Under the Plasma-drug Concentration Time Curve from time zero to time of last quantifiable concentration. Compare the pharmacokinetic (PK) properties of 300mg ARN-75039 with excipients in tablet form to 300mg neat ARN-75039 in HPMC capsules following oral administration under fed conditions.
AUC0-24
Time frame: From time zero (dose) to 24 hours post-dose.
Area under the plasma concentration-time curve from time zero to 24 hours post-dose. Compare the pharmacokinetic (PK) properties of 300mg ARN-75039 with excipients in tablet form to 300mg neat ARN-75039 in HPMC capsules following oral administration under fed conditions.
AUC0-∞
Time frame: From time zero (dose) extrapolated to infinity. Time frame is from 0 to Tlast + extrapolation from C last to infinity time, where concentration is equal to 0.
Area under plasma concentration-time curve from time zero to infinity. Compare the pharmacokinetic (PK) properties of 300mg ARN-75039 with excipients in tablet form to 300mg neat ARN-75039 in HPMC capsules following oral administration under fed conditions.
Cmax
Time frame: From time 0 (dose) through 168 hours post-dose.
Maximum observed plasma concentration. Compare the pharmacokinetic (PK) properties of 300mg ARN-75039 with excipients in tablet form to 300mg neat ARN-75039 in HPMC capsules following oral administration under fed conditions.
Tmax
Time frame: From time 0 (dose) through 168 hours post-dose.
Time to reach Cmax
t1/2
Time frame: From time 0 (dose) through 168 hours post-dose (terminal elimination phase).
Half-life
CL/F
Time frame: From time 0 (dose) through 168 hours post-dose (derived from the concentration-time profile).
Apparent clearance after extravascular administration.
Vz/F
Time frame: From time 0 (dose) through 168 hours post-dose (derived from the concentration-time profile).
Apparent volume of distribution during the terminal phase after extravascular administration.
3 secondary outcomes
Participants With ≥1 TEAE
Time frame: From first dose through approximately 7 days after the last dose (includes washout); with Day 36 follow-up phone call to assess for any adverse events (AEs).
Participants With ≥1 TESAE
Time frame: From first dose through approximately 7 days after the last dose (includes washout); with Day 36 follow-up phone call to assess for any adverse events (AEs).
Participants With Study Drug-related TEAEs of Grade >1
Time frame: From first dose through approximately 7 days after the last dose (includes washout); with Day 36 follow-up phone call to assess for any adverse events (AEs).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ken McCormack, PhD study chair
Arisan Therapeutics
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 ARN-75039 in people with Healthy Volunteer and Pharmacokinetics After Oral Intake, run by Arisan Therapeutics, Inc. 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 13 inclusion and 28 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 1 May 2026. 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?
Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
AUC0-t (time frame: From time zero (dose) to time of last quantifiable concentration. Period 1: 0 to 144 hours; Period 2: 0 to 168 hours.). The study lists 8 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 1 May 2026.