EUCTR2014-000284-40-GB
Active, not recruiting
Phase 1
An open label investigation of the tolerability and pharmacokinetics of oral cysteamine in adults with Cystic Fibrosis. - Cysteamine in Cystic Fibrosis (2)
niversity of Aberdeen0 sites12 target enrollmentApril 29, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Aberdeen
- Enrollment
- 12
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.CF related suppurative lung disease who expectorate sputum
- •2\.Clinically stable for \>4 weeks,
- •3\.Aged \=18 years,
- •4\.Weight \>50kg.
- •5\.Female participants of child bearing potential should be using a reliable form of contraception.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 11
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •1\.Hypersensitivity to the active substance, any form of cysteamine, or to any of the excipients.
- •2\.Hypersensitivity to penicillamine.
- •3\.Lung, liver transplant, on active transplant list.
- •4\.For women, current pregnancy or breast\-feeding, or planned pregnancy during the study.
- •5\.Any other significant disease/disorder which, in the investigator’s opinion, either puts the patient at risk because of study participation or may influence the results of the study or the patient's ability to participate in the study.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
An open-label investigation into the tolerability and pharmacokinetic / pharmacodynamic effects of sufugolix (TAK-013), at a dosage of 100mg twice-daily, during six months treatment of pre-menopausal women with endometriosis.symptomatic endometriosisMedDRA version: 7Level: LLTClassification code 10014778EUCTR2004-003829-28-GBTakeda Europe R&D Centre Ltd
Active, not recruiting
Not Applicable
An open-label investigation into the tolerability and pharmacokinetic / pharmacodynamic effects of sufugolix (TAK-013), at a dosage of 100mg twice-daily, during six months treatment of pre-menopausal women with endometriosis.symptomatic endometriosisMedDRA version: 7Level: LLTClassification code 10014778EUCTR2004-003829-28-DETakeda Europe R&D Centre Ltd20
Active, not recruiting
Phase 1
An open-label study to investigate the tolerability, pharmacokinetics and anti-tumor effect following photodynamic therapy (PDT) with single-ascending doses of LUZ11 in patients with advanced head and neck cancer.EUCTR2013-003133-14-PTuzitin, S.A.6
Active, not recruiting
Phase 1
A Clinical Study to evaluate the Safety, Tolerability, and the effects of VX-970 on its own and in combination with Carboplatin on the body in Subjects with Advanced Solid TumorsEUCTR2013-005100-34-GBVertex Pharmaceuticals Incorporated70
Completed
Not Applicable
An Open-Label Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of M4344 (formerly VX-803) as a Single Agent and in Combination With Cytotoxic Chemotherapy in Participants With Advanced Solid Tumorsadvanced solid tumorsSolid tumors10025319NL-OMON50338Merck16