Safety, Tolerability and Pharmacokinetics of BIIL 284 BS in Adult and Pediatric Cystic Fibrosis (CF) Patients
NCT02269189 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2014-10-21
Summary
Safety, tolerability and pharmacokinetics following repeated doses (15-day dosing)
Conditions
Interventions
- DRUG
-
BIIL 284 BS, high dose
- DRUG
-
BIIL 284 BS, low dose
- DRUG
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-04-30
- Primary Completion
- 2002-11-30
More Related Trials
-
Safety, Pharmacokinetics and Pharmacodynamics Study of Inhaled QBW276 in Patients With Cystic Fibrosis
NCT02566044 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis Patients
NCT02190604 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Adults With Cystic Fibrosis
NCT03029455 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients With Cystic Fibrosis
NCT06429176 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
NCT01710644 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Participants With Cystic Fibrosis (CF)
NCT05111145 ·Status: COMPLETED ·Phase: PHASE3
-
BI 443651 Multiple Rising Dose in Healthy Volunteers Followed by a Cross-over in CF Subjects
NCT02976519 ·Status: COMPLETED ·Phase: PHASE1
-
MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Cavosonstat (N91115) in Healthy Subjects (SNO-9)
NCT02934139 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis
NCT01347190 ·Status: COMPLETED ·Phase: PHASE1
-
Study Assessing PTI-428 Safety, Tolerability, Pharmacokinetics and Effect in Subjects With Cystic Fibrosis
NCT03591094 ·Status: COMPLETED ·Phase: PHASE2
-
Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis
NCT02718495 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety, Tolerability, and Pharmacokinetics of PTI-808, PTI-801, and PTI-428 Combination Therapy in Subjects With Cystic Fibrosis
NCT03500263 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Phase 1 Study to Evaluate the Relative Bioavailability of a VX-828 Tablet Formulation
NCT06861413 ·Status: COMPLETED ·Phase: PHASE1
-
PK Study of N91115 in Cystic Fibrosis Patients
NCT02227888 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate Safety, PK and PD of FDL169 in Cystic Fibrosis Subjects
NCT03093714 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety and Tolerability Study OF PUR118 In Subjects With Cystic Fibrosis
NCT01543191 ·Status: COMPLETED ·Phase: PHASE1
-
An Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing Mutations
NCT02934698 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
NCT03911713 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Safety, Tolerability & Efficacy in Cystic Fibrosis Patients With Abnormal Glucose Tolerance
NCT02955888 ·Status: TERMINATED ·Phase: PHASE2
-
Study of N91115 in Patients With Cystic Fibrosis Homozygous F508del-CFTR Mutation
NCT02275936 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis
NCT02951182 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QAU145 in Patients With Cystic Fibrosis
NCT00506792 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)
NCT05033080 ·Status: COMPLETED ·Phase: PHASE3
-
28 Day Repeat Dose in Cystic Fibrosis Patients
NCT00903201 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Chronic Incretin-based Therapy in Cystic Fibrosis
NCT01879228 ·Status: COMPLETED ·Phase: NA