Evaluating the Safety and Relative Bioavailability of Three SPN-817 Treatments (A, B and C) in Healthy Adult Subjects
NCT05102552 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2022-08-30
Summary
Randomized, Open-Label, Multiple Dose study to evaluate the relative bioavailability of Treatment A, Treatment B, and Treatment C
Conditions
- Healthy Volunteer
Interventions
- DRUG
-
SPN-817, Treatment B
SPN-817 Treatment B, is an Extended Release formulation of Huperzine A, an acetylcholinesterase inhibitor
- DRUG
-
SPN-817, Treatment C
SPN-817 Treatment C, is an Extended Release formulation of Huperzine A, an acetylcholinesterase inhibitor
- DRUG
-
BIS-001, Treatment A
BIS-001 is an Extended Release formulation of Huperzine A, an acetylcholinesterase inhibitor
Sponsors & Collaborators
-
Supernus Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Jeanelle Portelli, Ph.D. · Supernus Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-10-19
- Primary Completion
- 2022-03-25
- Completion
- 2022-08-15
Countries
- Australia
Study Locations
More Related Trials
-
Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 44370 TA Tablets in Healthy Male and Female Volunteers
NCT02215759 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181
NCT02044406 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809
NCT02068690 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test How BI 1819479 is Taken up and Processed by the Body
NCT07065617 ·Status: TERMINATED ·Phase: PHASE1
-
3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability
NCT05029518 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of BI 44370 TA Oral Drinking Solution in Healthy Male Volunteers
NCT02215018 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Men to Test How Different Doses of BI 1584862 Are Tolerated and How BI 1584862 is Taken up in the Body With or Without Food
NCT05520827 ·Status: COMPLETED ·Phase: PHASE1
-
Bioavailability of BI 1356 After Co-administration With Ritonavir Compared to the Bioavailability of BI 1356 Alone in Healthy Male Volunteers
NCT02183441 ·Status: COMPLETED ·Phase: PHASE1
-
Multiple Rising Dose of BI 1181181 Given Orally in Young Healthy Male and Elderly Healthy Male/Female Volunteers
NCT02254161 ·Status: TERMINATED ·Phase: PHASE1
-
Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Tablet Formulation in Healthy Volunteers
NCT02161432 ·Status: COMPLETED ·Phase: PHASE1
-
Bioavailability and Pharmacokinetics of BI 10773 Tablet in Healthy Male Volunteers
NCT02172209 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses and Effect of Food on the Bioavailability of BI 1060469
NCT01971502 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1, Single-Ascending-Dose Study of BT051 in Healthy Subjects
NCT05103878 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy People to Test How 2 Different Formulations of BI 690517 Are Taken up in the Body and How Probenecid Influences the Amount of BI 690517 in the Blood
NCT06647810 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Study of JNJ-42756493 in Healthy Participants
NCT02218073 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants
NCT06577259 ·Status: COMPLETED ·Phase: PHASE1
-
To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706
NCT01763333 ·Status: COMPLETED ·Phase: PHASE1
-
A Bioavailability and Pharmacokinetic Study of Subcutaneous and Intravenous RO6811135 in Healthy Volunteers
NCT01802853 ·Status: COMPLETED ·Phase: PHASE1
-
Single Rising Dose Study to Assess Safety, Tolerability and Pharmacokinetics of BI 661051.
NCT01343719 ·Status: COMPLETED ·Phase: PHASE1
-
Safety of Single Rising Doses and Relative Bioavailability of BI 691751
NCT01843972 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics and Safety of the Co-administration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Healthy Chinese Subjects
NCT02534870 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
NCT05515328 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113823 Powder in Bottle (PiB) and Tablet in Healthy Male Volunteers
NCT02259972 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers
NCT01594515 ·Status: COMPLETED ·Phase: PHASE1
-
Bioavailability and Pharmacokinetics of BI 135585 XX Administered as Tablet With and Without Food
NCT01286571 ·Status: COMPLETED ·Phase: PHASE1