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 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 prior to Day 15 will be asked to complete the Early Termination Visit 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
An oral therapy for the treatment of Lassa infection
Frontage
Secaucus, New Jersey, United States
AUC0-t
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.
Time frame: 36 days
AUC0-24
Area under the plasma concentration-time curve from time zero to 24 hours post-dose
Time frame: 36 days
AUC0-∞
Area under plasma concentration-time curve from time zero to infinity
Time frame: 36 days
Cmax
Maximum observed plasma concentration
Time frame: 36 days
Cmin0-24
Minimum observed plasma concentration from time zero to 24 hours post-dose
Time frame: 36 days
tmax
Time to reach Cmax
Time frame: 36 days
t1/2
Half-life
Time frame: 36 days
CL/F
Apparent clearance after extravascular administration
Time frame: 36 days
Vz/F
o Apparent volume of distribution during the terminal phase after extravascular administration
Time frame: 36 days
TEAEs
Type and frequency of treatment-emergent adverse events (TEAEs).
Time frame: 36 days
TESAEs
Type and frequency of treatment-emergent serious adverse events (TESAEs).
Time frame: 36 days
Greater than Grade 1 TEAEs
Type and frequency of study drug-related \>Grade 1 TEAEs
Time frame: 36 days
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