Clinical trials: sponsored by 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
Healthy
RTA 408 Lotion in Healthy Volunteers
This study is a first-in-human study of a topical dermal lotion formulation of RTA 408, a novel small molecule which suppresses oxidative stress and inflammation.
- Trial name
- NCT02029716
- Testing
- RTA 408 Lotion 0.5%, 1%, 3%
- Where
- United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteer
A Study to Find Out How BIIB141 (Omaveloxolone) Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping Milk
In this study, researchers will learn how BIIB141, also known as omaveloxolone or SKYCLARYS®, moves through the body. This is a drug available for doctors to prescribe for patients with Friedrich's Ataxia.
- Trial name
- NCT06612879
- Testing
- Omaveloxolone
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteer
A Study to Find Out How Multiple Doses of BIIB091 Affect the Electrical Activity of the Heart in Healthy Participants
In this study, researchers will learn how the heart reacts to multiple doses of BIIB091 in healthy participants. In previous studies looking at BIIB091, researchers have found that a certain range of doses can cause changes in…
- Trial name
- NCT06574828
- Testing
- BIIB091, Moxifloxacin
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteer
A Study to Find Out How Different Forms of BIIB091 is Processed in The Body With and Without Food in Healthy Participants
In this study, researchers will learn how the body processes new tablet forms of BIIB091 when taken with and without food. One new form of BIIB091 is an "extended release" tablet, also known as "ER." This form helps release…
- Trial name
- NCT06640933
- Testing
- BIIB091
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Biogen
Immune System Diseases, Autoimmunity
A Study of Safety and Drug Levels of HIB210 in Healthy Volunteers
The goal of this clinical trial is to test safety of the investigational product in healthy volunteers. The main questions it aims to answer is when HIB210 is administered as multiple doses, is it: 1. Safe 2. Well tolerated 3.
- Trial name
- NCT05928585
- Testing
- HIB210
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- HI-Bio, A Biogen Company
Healthy Volunteer
A Study to Assess the Potential for Gastric-pH Dependent Drug-Drug Interactions of BIIB122 With a Proton Pump Inhibitor in Healthy Participants
The primary objective of the study is to evaluate the effects of a proton pump inhibitor (PPI) [rabeprazole] on BIIB122 pharmacokinetics (PK) after a single dose in healthy participants.
- Trial name
- NCT06264440
- Testing
- BIIB122, Rabeprazole
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteer
A Study to Look at How a Single Oral Dose of Carbon-14-Labelled [14C] BIIB091 Moves Through and is Processed by the Body in Healthy Male Participants
The main goal of this study is to learn how [14C]-BIIB091 moves through and is processed by the body and to look at how much of BIIB091's metabolites (what is produced when BIIB091 is broken down by the body) appears in the…
- Trial name
- Mass Balance (NCT06311786)
- Testing
- [14C]-BIIB091
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteers
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB107 in Healthy Adult Participants
The primary objective is to determine the safety and tolerability of single and multiple ascending subcutaneous (SC) doses and a single intravenous (IV) dose of BIIB107 in healthy adult participants.
- Trial name
- NCT04593121
- Testing
- BIIB107
- Where
- 3 sites in United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteer
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, With Target Occupancy Study of BIIB113 in Healthy Participants
Parts A and B: The primary objective of this study is to evaluate the safety and tolerability of single and multiple ascending oral doses of BIIB113 in healthy participants.
- Trial name
- NCT05195008
- Testing
- BIIB113, 11^C]BIO-1819578
- Where
- 3 sites in Sweden, United Kingdom
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model
This study will assess the pharmacodynamic effects of SAGE-217 in approximately 42 healthy adult subjects using an insomnia model.
- Trial name
- NCT03284931
- Testing
- SAGE-217 high dose, SAGE-217 low dose
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Biogen
Mild Cognitive Impairment, Normal Aging
An Observational Study Using Multimodal Sensors to Measure Cognitive Health in Adults and Distinguish Mild Cognitive Impairment From Normal Aging
The primary objectives are to develop and validate a classifier using multimodal passive sensor data and metrics derived from normal iPhone and Apple Watch usage to distinguish individuals with normal cognition from those with…
- Trial name
- Intuition (NCT05058950)
- Where
- United States
- Volunteers
- 22,720 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
BIIB014 Effects on the Pharmacokinetics (PK) of Rosiglitazone, Warfarin, and Midazolam
The purpose of this study is to understand whether BIIB014 has potential to affect how certain drugs are broken down by the body.
- Trial name
- NCT01017666
- Testing
- BIIB014
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
Alternate Dosing Regimens of BG00012 in Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability, and PK of different doses and dosing regimens of BG00012 administered with and without ASA compared to placebo
- Trial name
- 109HV106 (NCT01281111)
- Testing
- Dimethyl Fumarate (BG00012), Aspirin
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteers
A Study to Evaluate Safety, Tolerability, and Distribution of a Microdose of Radiolabeled BIIB067 (99mTc-MAG3-BIIB067) Co-administered With BIIB067 (Tofersen) to Healthy Adults
The primary objective of the study is to evaluate the distribution in the central nervous system (CNS) of a microdose 99mTc-MAG3-BIIB067 co-administered with unlabeled BIIB067 (Tofersen).
- Trial name
- NCT03764488
- Testing
- Tofersen, 99mTc-MAG3-BIIB067
- Where
- 2 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteer
A Study to Evaluate Safety and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants
The primary objective of the study is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants.
- Trial name
- NCT05148481
- Testing
- BIIB104
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteers
Study of BIIB091 Formulations in Healthy Participants
The primary objectives of this study are: to evaluate the pharmacokinetic (PK) profiles of BIIB091 modified release (MR) formulations in healthy participants after single dose administration in the fasted state (Part 1); to…
- Trial name
- NCT04564612
- Testing
- BIIB091, Rabeprazole, Itraconazole
- Where
- United Kingdom
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Biogen