Oral Liquid 13-cis-retinoic Acid (13-CRA) (My-CRA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03291080|
Recruitment Status : Not yet recruiting
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: Liquid 13-Cis Retinoic Acid Drug: Extracted capsules 13-CRA||Phase 1 Phase 2|
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.
The pharmacokinetics of 13-CRA liquid (test product) and 200mg/m2/day 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Estimated Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||August 28, 2019|
|Estimated Study Completion Date :||October 28, 2019|
Oral liquid formulation of 13-Cis Retinoic Acid - test product.
Drug: Liquid 13-Cis Retinoic Acid
Liquid 13-Cis Retinoic Acid
Other Name: Isotretinoin
Isotretinoin capsules (13-CRA extracted per standard of care)- reference product.
Drug: Extracted capsules 13-CRA
Extracted capsules 13-CRA
Other Name: Isotretinoin
- PK- Relative bioavailability (population pharmacokinetic measures) [ Time Frame: On day 1 and 14 of treatment ]Non-linear, mixed effects modelling approach to determine the relative bioavailability and pharmacokinetics of 13-CRA administered as oral liquid and capsule formulations.
- Time to maximum concentration (Tmax) [ Time Frame: On day 1 and 14 of treatment ]Pharmacokinetic parameter
- Maximum plasma concentration (Cmax) [ Time Frame: On day 1 and 14 of treatment ]Pharmacokinetic parameter
- Area under plasma concentration time curve (AUC) [ Time Frame: On day 1 and 14 of treatment ]Pharmacokinetic parameter
- Half-life (t1/2) [ Time Frame: On day 1 and 14 of treatment ]Pharmacokinetic parameter
- Clearance (CL/F) [ Time Frame: On day 1 and 14 of treatment ]To determine clearance pharmacokinetics of 13-CRA
- Volume of distribution (V/F) [ Time Frame: On day 1 and 14 of treatment ]To determine volume of distribution pharmacokinetics of 13-CRA
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Over 2 months treatment and 14 day follow up ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291080
|Contact: Deborah Tweddle, MB ChB, MRCPfirstname.lastname@example.org|
|Study Director:||Hussain Mulla, PhD||Nova BioPharma Limited|