Clinical trials: CFD
Hepatic Impairment
Study of Danicopan in Participants With Hepatic Impairment
The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of ACH-0144471 (danicopan) in participants with hepatic impairment (HI) as compared to healthy matched participants.
- Trial name
- NCT03555539
- Testing
- Danicopan
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
Study of Radiolabeled ALXN2050 in Healthy Adult Males
This is an open-label study to assess the absorption, metabolism, excretion, and mass balance of a single oral dose of carbon-14 ([14C])-ALXN2050 in healthy adult males.
- Trial name
- NCT04609670
- Testing
- [14C]-ALXN2050
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
Study of Multiple Doses of Danicopan in Healthy Participants
This was a multiple ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants.
- Trial name
- NCT04889690
- Testing
- Danicopan
- Where
- New Zealand
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants
The purpose of this study was to evaluate and compare the plasma pharmacokinetic profiles of ACH-0144471 (danicopan) in healthy participants after administration of single oral doses of modified release prototype formulations.
- Trial name
- NCT03384186
- Testing
- Danicopan Modified Release Prototype 1, Danicopan Modified Release Prototype 2, Danicopan Modified Release Prototype 3
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
A Study of the Cardiac Effects of ALXN2050 in Healthy Adults
This is a randomized, double-blind, double-dummy, placebo- and positive-controlled parallel study to evaluate the effect of ALXN2050 on the QT interval in healthy adult participants.
- Trial name
- NCT04660890
- Testing
- ALXN2050, Moxifloxacin
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
A Drug Interaction Study Between Danicopan and Midazolam, Fexofenadine, and Mycophenolate Mofetil in Healthy Participants
The purpose of this study was to determine the potential drug interaction between danicopan (ACH-0144471) and midazolam, fexofenadine, and mycophenolate mofetil.
- Trial name
- NCT03108274
- Testing
- Danicopan, Midazolam, Fexofenadine
- Where
- New Zealand
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
A Study of Multiple Doses of ALXN2050 in Healthy Adults
This was a Phase 1, placebo-controlled, randomized, double-blind (participant and investigator blind, sponsor open), multiple-ascending dose study conducted in healthy participants to demonstrate the safety and tolerability and…
- Trial name
- NCT05047484
- Testing
- ALXN2050
- Where
- New Zealand
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
A Drug Interaction Study of ACH-0145228
This was a 2-part study (Part 1 and Part 2), with each part being an open-label, fixed sequence, 2-period study in healthy adult participants.
- Trial name
- NCT04709081
- Testing
- ACH-0145228, Midazolam, Digoxin
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
Study of the Metabolism of Danicopan in Healthy Adults
This is a 2-part open-label, randomized, single-dose, 3-sequence, 3-period crossover, relative bioavailability, and food-effect study comparing different formulations of danicopan in healthy adult participants.
- Trial name
- NCT04609696
- Testing
- Danicopan: Powder-In-Capsule 1, Danicopan: Powder-In-Capsule 2, Danicopan: Tablet
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Renal Impairment, Healthy
Study of ALXN2050 in Participants With Renal Impairment
This study will investigate the impact of impaired renal function on the plasma pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future indications in individuals with impaired renal function.
- Trial name
- NCT04623710
- Testing
- ALXN2050
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria
First-in-Human Study of BCX9930 in Healthy Volunteers and Patients With PNH
This is a 3-part Phase 1 dose-ranging study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single (Part 1) and multiple (Part 2) ascending doses of BCX9930 in healthy subjects and in subjects with…
- Trial name
- NCT04330534
- Testing
- BCX9930
- Where
- 4 sites in Austria, South Africa and 1 more
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- BioCryst Pharmaceuticals
Healthy
A Study of Single-dose ALXN2050 in Healthy Adults
This was a phase 1, first-in-human, single-center, randomized, double-blind (participants and investigator blind, sponsor open) placebo-controlled, single-ascending dose study of ACH-0145228 (ALXN2050) conducted in healthy adult…
- Trial name
- NCT05047458
- Testing
- ALXN2050
- Where
- New Zealand
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
Study of Danicopan in Participants of Japanese Descent
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of danicopan after a single-dose oral administration under fed and fasting conditions to participants of Japanese descent.
- Trial name
- NCT04451434
- Testing
- Danicopan
- Where
- Australia
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
Study of Different Forms of Danicopan (Tablet, Softgel Capsule, Liquid-filled Capsule) in Healthy Participants
This was a randomized, crossover, open-label study to assess the relative bioavailability, pharmacokinetics (PK), and safety of three different formulations of danicopan (tablet, softgel capsule, liquid-filled capsule [LFC]) in…
- Trial name
- NCT04940559
- Testing
- Danicopan - Tablet, Danicopan - Softgel, Danicopan - LFC
- Where
- New Zealand
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
A Study to Assess ACH-0145228 When Administered as Immediate Release Tablet Versus Powder-In-Capsule in Healthy Adult Participants
This will be an open-label, 3-sequence, 3-period crossover study in healthy adult participants to assess the relative bioavailability of ACH-0145228 when administered as an immediate release tablet versus powder-in-capsule.
- Trial name
- NCT04551586
- Testing
- ACH-0145228: Immediate Release, ACH-0145228: Powder-in-capsule
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy, Renal Dysfunction
Study of Danicopan in Participants With Normal Kidney Function and Participants With Kidney Dysfunction
This was an open-label, nonrandomized, multi-center, single-dose, parallel group study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan…
- Trial name
- NCT04935294
- Testing
- Danicopan
- Where
- 4 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Thoracic Outlet Syndrome, Sport Injury
CFD Analysis and Risk of TOS in Sport
Thoracic outlet syndrome (TOS) may complicate the activities of sporty subjects that participate in sports that involves upper extremities activities, such as baseball, tennis, swimming, rowing, volleyball, rugby football, and…
- Trial name
- COFLUTOSPO (NCT04428125)
- Testing
- Magnetic Resonance Scan of Thoracic outlet region, Duplex Ultrasound assessment of Upper limbs
- Where
- Italy
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Catanzaro
Atherosclerosis and Blood Flow in Coronary Artery
Geometrical Influences on Atherosclerosis and Blood Flow
The study investigates the use of advanced imaging techniques and computational methods to identify high-risk plaques in coronary arteries.
- Trial name
- NCT07002697
- Where
- Bangladesh
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bangladesh University of Engineering and Technology
Healthy
A Drug Interaction Study of Danicopan
This was a 3-part study (Part 1, Part 2, Part 3) with each part being an open-label, fixed sequence, 2-period study in healthy adult participants.
- Trial name
- NCT04709094
- Testing
- Danicopan, Warfarin, Bupropion
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Diabetes Mellitus, Type 2, Obesity
Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Obesity and Insulin Resistance
Being overweight or obese has been associated with insulin resistance contributing to an increased risk for the development of type II diabetes.
- Trial name
- NCT04926415
- Testing
- taVNS
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Burrell College of Health Sciences