Single-Dose Study of a New Formulation of BIIB061
NCT02521545 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2015-09-07
Summary
The primary objective of the study is to assess the pharmacokinetic (PK) profile of BIIB061 in the new oral formulation in the fasted state in healthy male and female volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BIIB061 in the new formulation in this study population.
Conditions
Interventions
- DRUG
-
BIIB061
Capsule
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Biogen
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-07-31
- Primary Completion
- 2015-08-31
- Completion
- 2015-08-31
Countries
- United States
Study Locations
More Related Trials
-
Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers
NCT02269930 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Learn About the Safety of BIIB091 and Its Effect on Brain Inflammation When Taken Alone or With Diroximel Fumarate (DRF) in Adults With Relapsing Forms of Multiple Sclerosis (MS)
NCT05798520 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis
NCT02219932 ·Status: COMPLETED ·Phase: PHASE3
-
A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple Sclerosis
NCT01917019 ·Status: COMPLETED ·Phase: PHASE3
-
An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple Sclerosis
NCT01462318 ·Status: COMPLETED ·Phase: PHASE3
-
A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
NCT02576717 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution and Repeatability of 11C-BMS-986196 After Intravenous (IV) Administration in Healthy Participants and After Repeat IV Administration in Participants With Multiple Sclerosis
NCT05064436 ·Status: TERMINATED ·Phase: PHASE1
-
A First Time in Human Study Exploring Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
NCT01808482 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
NCT06735248 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis
NCT00906399 ·Status: COMPLETED ·Phase: PHASE3
-
Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple Sclerosis
NCT01480076 ·Status: COMPLETED ·Phase: PHASE4
-
Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials.
NCT01235221 ·Status: COMPLETED ·Phase: PHASE3
-
Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF)and Safety in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)
NCT01181089 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple Sclerosis
NCT00879658 ·Status: COMPLETED ·Phase: PHASE2
-
Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis
NCT01199640 ·Status: COMPLETED ·Phase: PHASE2
-
This is a Randomized Study Comparing Two Doses of INT131 ( 3 mg and 1 mg) Administered Orally (PO) Daily (QD) Versus Placebo 1 Tablet PO QD in Subjects With Treatment-naïve RRMS for ≤ 3 Years
NCT02638038 ·Status: COMPLETED ·Phase: PHASE2
-
Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis.
NCT01597297 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS)
NCT04079088 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis
NCT03958877 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of MK-2225 in Healthy Participants (MK-2225-003)
NCT06643390 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)
NCT03222973 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis
NCT01064401 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
NCT00420212 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Pharmacokinetics and Pharmacodynamics Study With 2B3-201 in Healthy Subjects and Multiple Sclerosis(MS) Patients
NCT02048358 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Assess the Effects of MK0812 on Disease Activity in Patients With Relapsing-Remitting Multiple Sclerosis as Measured by Magnetic Resonance Imaging (MRI)(0812-003)(COMPLETED)
NCT00239655 ·Status: TERMINATED ·Phase: PHASE2