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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through 14 days post dose for sad cohorts and 28 days post last study dose for mad cohorts.
Awards & highlights
Study Summary
This trial tests the safety, tolerability, and how the body absorbs ARN-75039 in healthy adults over 6 or 10 weeks. 8 subjects in trial to assess food effect.
Eligible Conditions
- Lassa Fever
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through 14 days post dose for sad cohorts and 28 days post last study dose for mad cohorts.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through 14 days post dose for sad cohorts and 28 days post last study dose for mad cohorts.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The type and frequency of treatment-emergent adverse events (TEAEs)
Secondary outcome measures
Determination of plasma exposure (AUC0-t, AUC0-inf)
Determination of terminal half life
Determination of the recommended phase 2 dose (RP2D)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ARN-75039Experimental Treatment1 Intervention
Escalating single or multiple doses of ARN-75039 oral capsules
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo capsules in a same SAD and MAD dosing regimen as ARN-75039
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
The Defense Threat Reduction Agency (DTRA)UNKNOWN
Battelle Memorial InstituteOTHER
12 Previous Clinical Trials
1,749 Total Patients Enrolled
Arisan Therapeutics, Inc.Lead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You smoke more than 20 cigarettes, cigars, cigarillos, or use e-cigarettes per week in the 3 months before or during the study.You don't want to eat a high-fat breakfast on the days you take the study drug.You have any serious health conditions, as determined by the doctor in charge of the study.You should avoid eating Seville oranges, grapefruit, or drinking grapefruit juice 3 days before starting the study and during the study.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: ARN-75039
Awards:
This trial has 0 awards, including:Other Trials to Consider
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