Status:
COMPLETED
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
Lead Sponsor:
Arisan Therapeutics, Inc.
Conditions:
Lassa Virus Infection
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
ARN-75039-103 is a comparative, randomized, single-dose, crossover study to assess the PK, safety, and tolerability of neat ARN-75039 in hydroxypropyl methylcellulose (HPMC) capsules against ARN 75039...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
March 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06911242
Start Date
March 17 2025
End Date
April 21 2025
Last Update
May 18 2025
Active Locations (1)
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1
Frontage
Secaucus, New Jersey, United States, 07094