Trial · NCT03815695
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence, frequency, and severity of adverse events (AEs) per CTCAE v5.0 of a single ascending dose and multiple ascending doses of FT-4202 in adult healthy volunteers and SCD patients. | Up to 3 weeks of monitoring | |
| Primary | Maximum observed plasma concentration (Cmax) | Up to 3 weeks of testing | |
| Primary | Time to maximum observed plasma concentration (Tmax) | Up to 3 weeks of testing | |
| Primary | Area under the plasma concentration-time curve from time zero until the 24-hour time point (AUC0-24) | Up to 3 weeks of testing | |
| Primary | Area under the plasma concentration-time curve from time zero until the last quantifiable time point (AUC0-last) | Up to 3 weeks of testing | |
| Primary | Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) | Up to 3 weeks of testing | |
| Primary | Terminal elimination half-life (t1/2) | Up to 3 weeks of testing | |
| Primary | Apparent clearance (CL/F) | Up to 3 weeks of testing | |
| Primary | Apparent volume of distribution (Vd/F) | Up to 3 weeks of testing | |
| Primary | Terminal disposition rate constant (Lz) | Up to 3 weeks of testing | |
| Primary | Renal clearance (ClR) | Up to 3 weeks of testing | |
| Secondary | Change from baseline in the levels of 2,3-diphosphoglycerate (DPG) and adenosine triphosphate (ATP) in the red blood cells (RBCs) of healthy volunteers and SCD patients after single and multiple doses of FT-4202. | Up to 3 weeks of testing | |
| Secondary | Model-based estimate of change from baseline QT interval corrected using Fridericia's correction formula (QTcF) and 90% confidence interval at the estimated Cmax after a single dose of FT-4202 in healthy volunteers | up to 7 days | |
| Secondary | Change from baseline heart rate after a single dose of FT-4202 in healthy volunteers | up to 7 days | |
| Secondary | Change from baseline PR after a single dose of FT-4202 in healthy volunteers | up to 7 days | |
| Secondary | Change from baseline QRS after a single dose of FT-4202 in healthy volunteers | up to 7 days | |
| Secondary | Change from baseline T-wave morphology after a single dose of FT-4202 in healthy volunteers | up to 7 days |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03815695/registered