Safety and Pharmacokinetics of Sustained-release Depot Tacrolimus: A First-in-human Study
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|ClinicalTrials.gov Identifier: NCT03626714|
Recruitment Status : Completed
First Posted : August 13, 2018
Results First Posted : June 11, 2019
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Organ Transplant Rejection Psoriasis||Drug: Sustained Release Injectable Tacrolimus||Early Phase 1|
This is a first-in-human study to assess the safety and pharmacokinetic (PK) profile of sustained-release (SR) tacrolimus, which will be administered as a single dose of 0.1 mg/kg by subcutaneous (SC) injection in healthy subjects.
The short-term general investigational plan is to evaluate sustained release tacrolimus in healthy volunteers for up to 30 days in an exploratory trial to determine safety and drug concentrations in blood. The results from this study will inform the long-term goal of this program, which is to provide an improved treatment modality for prophylaxis of organ (kidney, liver and heart) transplant rejection with the additional benefit of enhancing medication compliance. These improvements have the potential to mitigate both the personal and economic burden of this disease.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, First-in-human, Safety and Pharmacokinetic Study of 1-Month Sustained-Release Injectable Tacrolimus in Healthy Subjects|
|Actual Study Start Date :||October 16, 2018|
|Actual Primary Completion Date :||January 5, 2019|
|Actual Study Completion Date :||January 5, 2019|
Experimental: Sustained Release Tacrolimus
All subjects will be treated with a single dose injection of sustained-release Tacrolimus
Drug: Sustained Release Injectable Tacrolimus
Long-acting formulation of tacrolimus developed using Auritec's proprietary Plexis drug delivery technology.
- Number of Subjects That Experienced Treatment-related Adverse Events [Safety and Tolerability] [ Time Frame: 60 days ]
Adverse events were documented at each study visit according to the criteria set forth in the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials as follows:
Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening).
- Drug Concentrations in Blood Samples at Individual Time-points [ Time Frame: 60 days ]The concentrations of tacrolimus in blood samples were measured at baseline, day 1 (1 hr, 3 hrs, 6 hrs, 12 hrs, and 24 hrs), followed by days 3, 7, 14, 21, 30, 37, 44, 51 and 60.
- Mean Blood Concentration-time Curve - Cmax [ Time Frame: 60 days ]Maximum observed tacrolimus whole blood concentration
- Mean Blood Concentration-time Curve - Tmax [ Time Frame: 60 days ]Time to maximum observed tacrolimus whole blood concentration
- Blood Concentration-time Curve [AUC] [ Time Frame: 60 days ]Area under the concentration-time curve
- Terminal Elimination Half-life [t1/2] [ Time Frame: 60 days ]The apparent terminal elimination half-life was calculated.
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): NCT03626714
|United States, Texas|
|Worldwide Clinical Trials|
|San Antonio, Texas, United States, 78217|
|Principal Investigator:||George J Atiee, MD||Worldwide Clinical Trials|