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NCT06911242 · ClinicalTrials.gov registry record · Phase 1
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 of Lassa Virus Infection, sponsored by Arisan Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT06911242: Completed Phase 1 study of Lassa Virus Infection, sponsored by Arisan Therapeutics.
NCT06911242 is a Phase 1 study of Lassa Virus Infection that has completed, run by Arisan Therapeutics. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06911242, a Phase 1 study of Lassa Virus Infection, has completed, sponsored by Arisan Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study 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 with excipients in tablet form administered by the oral route 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, prior to 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: * Period 1: Neat ARN-75039 in HPMC capsules (reference product) * Period 2: ARN-75039 with excipients in tablet form (comparator) * Sequence 2: * Period 1: ARN-75039 with excipients in tablet form (comparator) * Period 2: 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 prior to dosing of period 1 (Day -1). Participants that are eligible to parti
Conditions Studied
Interventions
- DRUG ARN-75039
Study Locations (1)
New Jersey
- Frontage - Secaucus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2025-03-17 |
| Est. Completion | 2025-04-21 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06911242
The ClinicalTrials.gov registry entry for NCT06911242 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). The listed sponsor is Arisan Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lassa Virus Infection appearing as the primary indexed condition, and to 1 intervention - of which ARN-75039 is the first listed.
NCT06911242 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT06911242 about?
NCT06911242 is a clinical study titled "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". 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 with excipients in tablet form administered by the oral route in healthy adult participants. The sa...
What is the current status of trial NCT06911242?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2025-03-17. Estimated completion is 2025-04-21.
What conditions does trial NCT06911242 study?
This clinical trial studies the following conditions: Lassa Virus Infection.
What interventions are being tested in trial NCT06911242?
The interventions under investigation include: ARN-75039 (DRUG).
Who is sponsoring clinical trial NCT06911242?
This trial is sponsored by Arisan Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06911242 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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