Trials / Completed
CompletedNCT03291080
Oral Liquid 13-cis-retinoic Acid (13-CRA)
Relative Bioavailability and Comparative Pharmacokinetics of 13-CRA Oral Liquid and Extracted Capsule Formulations: a Randomised, Open Label, Multi-dose, Cross-over Clinical Trial in Patients Requiring Treatment Cycles of 13-CRA.
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Nova Laboratories Limited · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
An open label, randomised, multiple dose, cross-over relative bioavailability and pharmacokinetics trial of a novel oral liquid and capsule formulations of 13-CRA administered to patients from 0 months - \< 21 years.
Detailed description
All patients requiring at least two cycles of 13-CRA therapy will be eligible for recruitment into the trial. 13-CRA will be prescribed to patients according to local treatment protocols at each clinical site. The dose administered will be 200mg/m2/day for both test and reference product. Patients with a body weight of ≤12kg will receive a dose of 160 mg/m2/day. The pharmacokinetics of 13-CRA liquid (test product) and extracted from capsule (reference product) will be evaluated over two months. Prior to the initiation of 13-CRA treatment as part of the trial, patients will be randomised to receive either liquid or capsule formulation in "My-CRA month 1". The patients will then cross-over to the alternative formulation in "My-CRA month 2". The patients on the trial who require further treatment will revert to standard therapy i.e. 13-CRA extracted from capsules according to local practice.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Liquid 13-Cis Retinoic Acid | Liquid 13-Cis Retinoic Acid |
| DRUG | Extracted capsules 13-CRA | Extracted capsules 13-CRA |
Timeline
- Start date
- 2018-04-17
- Primary completion
- 2019-09-12
- Completion
- 2019-09-12
- First posted
- 2017-09-25
- Last updated
- 2021-10-19
- Results posted
- 2021-10-19
Locations
10 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03291080. Inclusion in this directory is not an endorsement.