Clinical trials: Cystic Fibrosis
- Condition Cystic Fibrosis
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Cystic Fibrosis
Effect of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) on the PK of Rosuvastatin in Healthy Participants
The purpose of this study is to evaluate the effect of multiple doses of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) on the PK of rosuvastatin and the safety and tolerability of coadministration of VNZ/TEZ/D-IVA with…
- Trial name
- NCT07349394
- Testing
- VNZ/TEZ/D-IVA, Rosuvastatin
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD001 in Healthy Subjects
This is a first in human study of ETD001 a new drug being developed for the treatment of cystic fibrosis. The study is a randomised, placebo-controlled, double-blind interventional study to assess the safety, tolerability and…
- Trial name
- NCT04926701
- Testing
- ETD001 single dose, ETD001 multiple twice daily doses, ETD001 multiple once daily doses
- Where
- United Kingdom
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Enterprise Therapeutics Ltd
Cystic Fibrosis
A Phase 1 Study to Evaluate the Relative Bioavailability of a VX-828 Tablet Formulation
The purpose of this study is to evaluate the relative bioavailability of a VX-828 tablet formulation compared to a suspension and evaluate its safety and tolerability.
- Trial name
- NCT06861413
- Testing
- VX-828
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis (CF)
Safety, Tolerability and Pharmacokinetics Study of AIR DNAse Administered by Inhalation to Healthy Adult Volunteers
This study will be performed to assess the safety, tolerability and PK of escalating inhaled AIR-DNase doses administered as a single dose followed by multiple doses for 5 consecutive days in healthy subjects.
- Trial name
- NCT02605590
- Testing
- AIR DNase
- Where
- Israel
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Protalix
Healthy Volunteer - Complete, Cystic Fibrosis - Complete
Study Designed to Assess the Safety, Tolerability and PK of PTI-808 in Healthy Volunteers and in Adults With Cystic Fibrosis
Part 1 of this trial will enroll healthy volunteers into a single ascending dose (SAD), multiple ascending dose (MAD), and Food Effect (FE) treatment groups.
- Trial name
- NCT03251092
- Testing
- PTI-808, PTI-428, PTI-801
- Where
- 48 sites in United States, Australia and 7 more
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Proteostasis Therapeutics, Inc.
Cystic Fibrosis
An Electrocardiogram Study to Evaluate the Effect of Vanzacaftor on the QT/QTc Interval in Healthy Participants
The purpose of this study is to evaluate the effect of Vanzacaftor (VNZ) on QTcF, as well as the pharmacokinetic (PK), safety, and tolerability of VNZ in healthy participants.
- Trial name
- NCT05867147
- Testing
- Vanzacaftor, Moxifloxacin
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
In Development for Cystic Fibrosis
Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects
The purpose of this study is to investigate the pharmacokinetics and safety of a single dose of VX-770 in subjects with moderate hepatic impairment.
- Trial name
- NCT01208285
- Testing
- VX-770
- Where
- 3 sites in Czechia, Slovakia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA)
The purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of VNZ/TEZ/D-IVA.
- Trial name
- NCT06299709
- Testing
- VNZ/TEZ/D-IVA
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects
The purpose of this study is to examine the drug-drug interaction effects of ciprofloxacin, itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with ivacaftor as well as to evaluate the potential…
- Trial name
- NCT01768663
- Testing
- Lumacaftor, Ivacaftor, Ciprofloxacin
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Healthy Volunteer
Bioequivalence and Food Effect Bioavailability Study of Lumacaftor Film-Coated Tablets
The objective of this study is to assess bioequivalence of lumacaftor from Lumacaftor 200 mg Film-Coated Tablet Formulation (Qanatpharma) versus the reference commercial product, Lumacaftor 200 mg /Ivacaftor 125 mg Combination…
- Trial name
- NCT05968612
- Testing
- Lumacaftor 200 mg/Ivacaftor 125 mg Film-Coated Tablet, Lumacaftor 200 mg Film-Coated Tablet Formulation
- Where
- Canada
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Qanatpharma Canada LTD
Cystic Fibrosis
A Study to Evaluate Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Adults With Cystic Fibrosis
Evaluate the safety and tolerability of VX-659 in healthy subjects
- Trial name
- NCT03029455
- Testing
- VX-659, Tezacaftor, Ivacaftor
- Where
- 10 sites in United Kingdom
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis, Chronic Obstructive Pulmonary Disease
A Phase 1 Study to Characterize the Effect of GS-5737 Enhancement of Mucociliary Clearance (MCC) in Healthy Subjects
This is a randomized, double-blind, cross-over, vehicle-controlled study to determine whether GS-5737 in 2.8% saline accelerates mucociliary clearance (MCC) in healthy subjects, compared to vehicle of 2.8% saline alone.
- Trial name
- NCT01793649
- Testing
- GS-5737
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Cystic Fibrosis
Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male Volunteers
The purpose of this study is to evaluate the safety and tolerability of escalating doses of GS-9411 in healthy male volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway hydration and mucociliary clearance in…
- Trial name
- NCT00800579
- Testing
- GS-9411
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Healthy Volunteer, Cystic Fibrosis
Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis
This trial will consist of two parts: Part 1 and Part 2. Part 1 will enroll adult healthy volunteers (HV) into four treatment groups.
- Trial name
- NCT03140527
- Testing
- PTI-801, PTI-808
- Where
- 38 sites in United States, Canada and 3 more
- Volunteers
- 171 people, healthy volunteers welcome
- Sponsor
- Proteostasis Therapeutics, Inc.
In Development for Cystic Fibrosis
Study of VX-770 on Desipramine
The objective of this study is to evaluate the effects of VX-770 on Desipramine
- Trial name
- NCT01153542
- Testing
- VX-770
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Healthy Subjects, Cystic Fibrosis
A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of IONIS-ENaCRx in Healthy Volunteers and Patients With Cystic Fibrosis
This Phase 1/2a study is a double-blinded (subject and Investigator), randomized, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple…
- Trial name
- NCT03647228
- Testing
- IONIS-ENaCRx
- Where
- 8 sites in Germany, United Kingdom
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Ionis Pharmaceuticals, Inc.
Cystic Fibrosis
A Study to Evaluate the Relative Bioavailability of a Fixed-dose Combination Tablet of VX-121/Tezacaftor/Deutivacaftor
The purpose of this study is to evaluate the relative bioavailability of a fixed-dose combination tablet (FDC) of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA).
- Trial name
- NCT05535959
- Testing
- VX-121/TEZ/D-IVA
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Safety and Efficacy of Inhaled OligoG CF-5/20 for the Treatment Cystic Fibrosis
Cystic fibrosis (CF) is a disease caused by a mutation in the gene that makes the cystic fibrosis transmembrane regulator protein.
- Trial name
- NCT00970346
- Testing
- OligoG CF-5/20
- Where
- United Kingdom
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- AlgiPharma AS
Non-Cystic Fibrosis Bronchiectasis, Cystic Fibrosis
A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects
Human Neutrophil Elastase (HNE) plays a pivotal role in innate immunity and in neutrophilic lung inflammation that characterized many diseases.
- Trial name
- CHF6333 FIH (NCT03056326)
- Testing
- CHF6333 (Part 1 - SAD), CHF6333 (Part 2 - MAD)
- Where
- Belgium
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Cystic Fibrosis
To Assess the Safety, Tolerability and Pharmacokinetics of AZD5634 Following Inhaled and Intravenous (IV)Dose Administration
This is a Phase 1, first-in-human (FIH) single ascending dose study being conducted to better understand the safety, tolerability and pharmacokinetics of AZD5634 in healthy subjects
- Trial name
- NCT02679729
- Testing
- AZD5634 for inhalation, AZD5634 for infusion
- Where
- 2 sites in United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- AstraZeneca