Trials / Completed
CompletedNCT05413551
Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 73 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This trial is designed to determine whether modifying the dose of isoniazid for individuals according to their n-acetyltransferase 2 (NAT2) genotype could increase the probability of achieving equivalence of area-under-the-curve.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Low-dose isoniazid | Pharmacogenomic-modified dose of isoniazid - 5 mg/kg oral tablet (maximum 300 mg) |
| DRUG | Standard dose of isoniazid | 15 mg/kg oral tablet (up to 900 mg) |
| DRUG | High-dose isoniazid | Pharmacogenomic-modified dose of isoniazid - 25 mg/kg oral tablet (maximum 1500 mg) |
Timeline
- Start date
- 2023-03-23
- Primary completion
- 2025-04-23
- Completion
- 2025-06-25
- First posted
- 2022-06-10
- Last updated
- 2025-12-17
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT05413551. Inclusion in this directory is not an endorsement.