Clinical trials: completed, sponsored by Biogen
Healthy Volunteer
A Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled Diranersen (BIIB080) Co-administered With Diranersen in Healthy Adults
In this study, researchers will learn more about a study drug called diranersen (BIIB080). Diranersen is currently a drug under investigation for treatment of Alzheimer's disease.
- Trial name
- NCT06454721
- Testing
- [89Zr]Zr-DFO-Diranersen, Diranersen
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteer
A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways
In this study, researchers will learn how the body processes litifilimab when it is given under the skin in 3 different ways. Currently, ongoing studies utilize pre-filled syringes (PFS) that can deliver litifilimab…
- Trial name
- NCT06741657
- Testing
- Litifilimab, AI, OBI
- Where
- 2 sites in United States
- Volunteers
- 404 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteer
A Study to Learn How the Body Processes BIIB141 (Omaveloxolone) When Taken as a Capsule or as a Tablet Dissolved in Liquid, and to Learn About Its Safety in Healthy Adults Ages 18 to 55
In this study, researchers will learn more about BIIB141, also known as omaveloxolone or SKYCLARYS®. This drug has been approved, or made available for doctors to prescribe, for people with Friedrich's Ataxia (FA) who are at…
- Trial name
- NCT07297199
- Testing
- Omaveloxolone
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteer
A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 18 to 55
In this study, researchers will learn more about BIIB141, also known as omaveloxolone or SKYCLARYS®. This drug has been approved, or made available for doctors to prescribe, for people with Friedrich's Ataxia (FA) who are at…
- Trial name
- NCT07149415
- Testing
- Omaveloxolone, Omeprazole
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteer
A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants
The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants.
- Trial name
- NCT06262477
- Testing
- BIIB800, Actemra
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteer
A Study to Learn How BIIB141 (Omaveloxolone) is Processed in the Body When Taken as Capsules Compared to Sprinkled on Yogurt in Healthy Adults Aged 18 to 55
In this study, researchers will learn more about how BIIB141, also known as omaveloxolone or SKYCLARYS®, is processed in the body when taken in different ways.
- Trial name
- NCT07019064
- Testing
- Omaveloxolone
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Biogen
Hepatic Impairment
A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic Function
This study will examine the pharmacokinetics (PK) of omaveloxolone following a single oral dose of omaveloxolone in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic…
- Trial name
- NCT03902002
- Testing
- Omaveloxolone 50 mg capsules
- Where
- 3 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Male Subjects
A Human AME Study for Omaveloxolone
This study will assess the pharmacokinetics (PK), mass balance, metabolite profiles, and rates and routes of elimination of [14C] omaveloxolone and derived metabolites following administration as a single 150 mg (containing…
- Trial name
- NCT03931590
- Testing
- [14C]-Omaveloxolone
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Biogen
Health Adult Subjects
A TQTc Study for Omaveloxolone
This is a randomized, double blind, placebo and active (moxifloxacin open label) controlled study in healthy subjects to assess the effect of the supratherapeutic exposure of omaveloxolone on QTc interval.
- Trial name
- NCT05927649
- Testing
- Omaveloxolone, Moxifloxacin
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers
This study will determine the effect of food on the pharmacokinetics of omaveloxolone (150 mg) in healthy adult subjects and will assess the safety, tolerability, and dose proportionality of 50 mg, 100 mg, and 150 mg…
- Trial name
- NCT03664453
- Testing
- omaveloxolone
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Adult Subjects
An Open-label DDI Study of Omaveloxolone in Healthy Subjects
This is an open-label, single-sequence, 2-period crossover study in healthy subjects. In this study, 20 subjects will be enrolled to allow at least 16 evaluable subjects.
- Trial name
- NCT05909644
- Testing
- Omaveloxolone, Efavirenz
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Adult Subjects
A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone
This study will assess the potential for clinical drug-drug interactions between omaveloxolone and a number of substrates and inhibitors of metabolic enzymes and drug transporters.
- Trial name
- NCT04008186
- Testing
- Omaveloxolone, Midazolam oral solution, Repaglinide 1 MG
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteers
Effect of Itraconazole on the Pharmacokinetics of Bardoxolone Methyl in Healthy Adults
This trial will study the impact of a strong CYP3A4 inhibitor (itraconazole) on the pharmacokinetics of bardoxolone methyl (RTA 402) in healthy adult subjects.
- Trial name
- NCT03264079
- Testing
- Bardoxolone methyl capsules 10 mg, Itraconazole capsules 100 mg
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteers
Multiple-Dose Study of Effect of Bardoxolone Methyl on QT/QTC Interval Volunteers
This is a single-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, active-comparator, parallel study in healthy volunteers.
- Trial name
- NCT01689116
- Testing
- Bardoxolone Methyl 20mg, Bardoxolone Methyl 80mg, Moxifloxacin 400mg
- Where
- United States
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteers
An Open-Label Study of the Effect of Bardoxolone Methyl on the Single Dose Pharmacokinetics of Digoxin and Rosuvastatin in Healthy Volunteers
The purpose of this study is to evaluate the potential effect of bardoxolone methyl on the pharmacokinetics of digoxin and rosuvastatin and to assess the safety of the concomitant administration of bardoxolone methyl with digoxin…
- Trial name
- NCT01598363
- Testing
- Digoxin, Rosuvastatin
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
A Phase I Study to Investigate the Absorption, Metabolism and Excretion in Healthy Male Subjects
The purpose of this study is to determine the absorption and excretion kinetics of bardoxolone methyl and to determine and characterize metabolites present in plasma, urine and feces in men following a single oral does or 20 mg…
- Trial name
- NCT01503866
- Testing
- bardoxolone methyl
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Biogen
Hepatic Impairment, Healthy
Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function
The purpose of this study is to assess the pharmacokinetic profile of bardoxolone methyl following a single oral dose of 20 mg bardoxolone methyl in subjects with mild, moderate, and severe hepatic impairment, as compared to…
- Trial name
- NCT01563562
- Testing
- Bardoxolone Methyl
- Where
- 2 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
Safety and PK/PD of RTA 1701 in Healthy Adults
This first-in-human, Phase 1, single-center study will evaluate single ascending doses (SAD) and multiple ascending doses (MAD) of RTA 1701 conducted in 2 parts.
- Trial name
- NCT03579030
- Testing
- RTA 1701 capsules
- Where
- Australia
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteers
A Single-Dose, Open-Label, Randomized, Food Effect and Blinded, Randomized, Dose Proportionality Study in Healthy Volunteers With Bardoxolone Methyl
This study is to determine the effect of food on a single dose of 20 mg bardoxolone methyl administered to normal healthy adult subjects.
- Trial name
- NCT01461161
- Testing
- bardoxolone methyl
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
A Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of RTA 901 in Healthy Adults
This study will assess the safety, tolerability, and pharmacokinetic profile of RTA 901 following escalating single and multiple oral doses of RTA 901 in healthy adult subjects.
- Trial name
- NCT02666963
- Testing
- RTA 901 Capsules, 10 or 40 mg
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Biogen