Trial · NCT03815695
A SAD/MAD to Assess the Safety, PK/PD of FT-4202 in Healthy Volunteers and Sickle Cell Disease Patients
NCT03815695, Phase 1, Completed, Forma Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A SAD/MAD to Assess the Safety, PK/PD of FT-4202 in Healthy Volunteers and Sickle Cell Disease Patients. Trials, record NCT03815695. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03815695
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A SAD/MAD to Assess the Safety, PK/PD of FT-4202 in Healthy Volunteers and Sickle Cell Disease Patients
- NCT number
- NCT03815695
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 130 participants, actual
- Lead sponsor
- Forma Therapeutics, Inc.
- Conditions
- Healthy Volunteers, Sickle Cell Disease
- Interventions
- FT-4202/Placebo
- First posted
- 2019-01-24
- Last updated
- 2024-04-10
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03815695
GET https://conductscience.org/api/trials/v1/NCT03815695/registered