Clinical trials: CFD
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.
Lupus Nephritis, Immunoglobulin A Nephropathy
Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of ALXN2050 (120 and 180 milligrams [mg]) in addition to background therapy consistent with the standard of care in adult participants (≥ 18 to ≤…
- Conditions
- Lupus Nephritis, Immunoglobulin A Nephropathy, IgAN, LN
- Trial name
- NCT05097989
- Testing
- ALXN2050
- Where
- 71 sites in United States, Argentina and 14 more
- Volunteers
- 100 people
- 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.
Paroxysmal Nocturnal Hemoglobinuria, PNH
A Long-Term Safety Study of BCX9930 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
This study was designed to evaluate the long-term safety of daily oral treatment with BCX9930 in participants who had participated in a previous BCX9930 trial for PNH and showed a benefit of treatment as determined by the…
- Trial name
- NCT04702568
- Testing
- BCX9930, Eculizumab, Ravulizumab
- Where
- 5 sites in Austria, South Africa and 1 more
- Volunteers
- 19 people
- Sponsor
- BioCryst Pharmaceuticals
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.
Paroxysmal Nocturnal Hemoglobinuria (PNH)
BCX9930 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in Participants Not Receiving Other Complement Inhibitor Therapy
The purpose of this study was to determine the efficacy and safety of BCX9930 monotherapy for the treatment of adult participants with PNH not currently receiving complement inhibitor therapy.
- Trial name
- REDEEM-2 (NCT05116787)
- Testing
- BCX9930 monotherapy
- Where
- 5 sites in Malaysia, South Africa and 1 more
- Volunteers
- 12 people
- Sponsor
- BioCryst Pharmaceuticals
Pulmonary Disease, Chronic Obstructive
Research to Evaluate a Possible Relation Between Values Obtained After Processing CT Images, Lung Function Tests and the Experience of the Patient During an Exacerbation in COPD Patients.
In this study the consequences of exacerbations will be visualized by high resolution computed tomography (HRCT) scan at functional residual capacity (FRC) and total lung capacity (TLC) as taken during an episode of exacerbation…
- Trial name
- NCT01684384
- Testing
- Functional Respiratory Imaging
- Where
- 4 sites in Belgium, Italy and 1 more
- Volunteers
- 53 people
- Sponsor
- FLUIDDA nv
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.
Paroxysmal Nocturnal Hemoglobinuria
Dose Escalation of BCX10013 in Participants with Paroxysmal Nocturnal Hemoglobinuria (PNH)
This is a multicenter, open-label, intra-subject, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and therapeutic potential of BCX10013 in participants with PNH.
- Trial name
- NCT06100900
- Testing
- BCX10013
- Where
- 4 sites in Malaysia, South Africa
- Volunteers
- 8 people
- Sponsor
- BioCryst Pharmaceuticals
Healthy
Study of a Single Dose of Danicopan in Healthy Participants
This was a single ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants.
- Trial name
- NCT04889677
- Testing
- Danicopan
- Where
- New Zealand
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
Drug-Drug Interaction (DDI) Study of ALXN2050 in Healthy Adult Participants
This study will evaluate the potential drug interactions between ALXN2050 and cyclosporine (Part 1), between ALXN2050 and tacrolimus (Part 2), and between ALXN2050 and mycophenolate mofetil (MMF) (Part 3).
- Trial name
- NCT05202145
- Testing
- ALXN2050, Cyclosporine, Tacrolimus
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
A Study of the Effects of Food and Age on Danicopan
This will be an open-label, 2-part study. Part 1 will be a randomized, 2-sequence, 2-period crossover, food-effect study in healthy young adult participants.
- Trial name
- NCT04551599
- Testing
- Danicopan
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
C3 Glomerulonephritis, C3 Glomerulopathy
A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471
The primary purpose of this study was to evaluate the efficacy of 12 months of oral ACH-0144471 (also known as danicopan and ALXN2040) in participants with C3G or IC-MPGN based on histologic scoring and proteinuria.
- Conditions
- C3 Glomerulonephritis, C3 Glomerulopathy, Immune Complex Membranoproliferative Glomerulonephritis, IC-MPGN
- Trial name
- NCT03459443
- Testing
- Danicopan
- Where
- 13 sites in United States, Australia and 3 more
- Volunteers
- 22 people
- Sponsor
- Alexion Pharmaceuticals, Inc.