Trial · NCT03096080
A Safety, Pharmacokinetic, Single Ascending Dose Study of Tesevatinib in Pediatric Subjects With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
NCT03096080, Phase 1, Completed, Kadmon Corporation, LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety, Pharmacokinetic, Single Ascending Dose Study of Tesevatinib in Pediatric Subjects With Autosomal Recessive Polycystic Kidney Disease (ARPKD). Trials, record NCT03096080. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03096080
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety, Pharmacokinetic, Single Ascending Dose Study of Tesevatinib in Pediatric Subjects With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
- NCT number
- NCT03096080
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 10 participants, actual
- Lead sponsor
- Kadmon Corporation, LLC
- Conditions
- Polycystic Kidney, Autosomal Recessive
- Interventions
- Tesevatinib
- First posted
- 2017-03-30
- Last updated
- 2022-05-11
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluation of the safety and tolerability of a single dose tesevatinib liquid formulation in pediatric participants with ARPKD | 2 weeks | Safety and tolerability endpoints will be measured with the aggregated results of frequency and severity of adverse events and safety assessments (e.g. clinical laboratory tests, physical examinations, vital signs, ECGs, audiology testing, ocular monitoring) |
| Secondary | Evaluation of the time to peak of plasma concentration of a single dose of tesevatinib liquid formulation in pediatric participants with ARPKD. | 3 days | Pharmacokinetic parameter Tmax for tesevatinib will be measured as time elapsed till peak concentration. |
| Secondary | Evaluation of the plasma maximum concentration of a single dose of tesevatinib liquid formulation in pediatric participants with ARPKD. | 3 days | Pharmacokinetic parameter Cmax for tesevatinib will be used to measure the highest concentration of the drug in plasma. |
| Secondary | Evaluation of the Area Under the Curve (AUC) of plasma concentration against time 0-Last hours from the single dose administration of tesevatinib liquid formulation in pediatric participants with ARPKD. | 3 days | Pharmacokinetic parameter AUC0-Last for tesevatinib will be measured and summarized by dose. |
| Secondary | Evaluation of the Area Under the Curve (AUC) of plasma concentration against time 0-24 hours from the single dose administration of tesevatinib liquid formulation in pediatric participants with ARPKD. | 3 days | Pharmacokinetic parameter AUC0-24 for tesevatinib will be measured and summarized by dose. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03096080
GET https://conductscience.org/api/trials/v1/NCT03096080/registered