Histamine Receptor 2 Antagonists as Enhancers of Anti-Tumour Immunity
Keywords
Abstract
Dates
| Last Verified: | 02/28/2019 |
| First Submitted: | 04/25/2017 |
| Estimated Enrollment Submitted: | 05/03/2017 |
| First Posted: | 05/08/2017 |
| Last Update Submitted: | 03/07/2019 |
| Last Update Posted: | 03/10/2019 |
| Actual Study Start Date: | 04/30/2018 |
| Estimated Primary Completion Date: | 10/31/2019 |
| Estimated Study Completion Date: | 10/31/2019 |
Condition or disease
Intervention/treatment
Drug: Treatment Group
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Treatment Group This is a one arm study in which all individuals receive the treatment; therefore there is no allocation or randomization.
Thirty subjects will receive ranitidine to a maximum of 900 mg/day in 2 daily doses for 6 weeks. The dosage target is 8 mg/kg/day, but the range of ranitidine intake will be between 7.5- 9 mg/kg/day. This is due to the formulation of the tablets, sold as 75, 150, and 300mg tablets. The ranitidine will be taken orally. | Drug: Treatment Group Thirty subjects will receive Ranitidine to a maximum of 900 mg/day in 2 daily oral doses for 6 weeks. The dosage target is 8 mg/kg/day, but the range of ranitidine intake will be between 7.5- 9 mg/kg/day. This is due to the formulation of the tablets, sold as 75, 150, and 300mg tablets. |
Eligibility Criteria
| Ages Eligible for Study | 20 Years To 20 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Age 20-50 years old, all sexes or genders - Veins acceptable for blood draw - Able to provide informed consent - eGFR > 90 mL/min/1.73m2 - Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ECG, urinalysis). Clinical laboratory values within stated normal range; if not within this range, they must be without clinical significance - Female volunteers who are of childbearing potential that agree to use of the accepted contraceptive regimens from at least 21 days prior to the first administration of study drug, during the study, and for at least 30 days after the last dose of study drug - Female volunteers who are postmenopausal (no menses for at least 1 year, or surgically sterile Exclusion Criteria: - Use of ranitidine for greater than 1 week within 6 months of starting the study - Medical requirement for ranitidine use - Current or past diagnosis of: porphyria, cancer, immune deficiency disorder - Active infection at the time of screening - Known liver, hematologic, renal disease - Past history of allergic reaction to ranitidine or past history of hypersensitivity to any ingredient in the formulation or past history of hypersensitivity to other drugs - Pregnant, planning to be pregnant, or breastfeeding during the study period - Weight (kg) exceeds 109kg |
Outcome
Primary Outcome Measures
1. Intra-individual frequency and function of immune cell subsets [Frequency and function were calculated as the values at 6 wks after treatment compared to the values at baseline.]
Secondary Outcome Measures
1. Inter-individual frequency and function of immune cell subsets [Frequency and function were calculated as the values at 6 wks after treatment compared to the values at baseline.]
