Trial · NCT04135495
A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD of ELX-02 in Cystic Fibrosis Patients With G542X Allele
NCT04135495, Phase 2, Completed, Eloxx Pharmaceuticals, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD of ELX-02 in Cystic Fibrosis Patients With G542X Allele. Trials, record NCT04135495. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04135495
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD of ELX-02 in Cystic Fibrosis Patients With G542X Allele
- NCT number
- NCT04135495
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Eloxx Pharmaceuticals, Inc.
- Conditions
- Cystic Fibrosis
- Interventions
- ELX-02, Ivacaftor
- First posted
- 2019-10-22
- Last updated
- 2022-11-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | AEs associated with different dose levels of ELX-02 | From the time of first dosing through the follow-up visit, an average of approximately 9 weeks | |
| Primary | Area under the plasma concentration curve from time zero to 24 hours (AUC0-24h) | Day 1 of treatment periods 1, 2, 3, and 4 | Full PK profile 8 blood samples over 24 hours |
| Primary | Maximum observed plasma concentration (Cmax) on Day 1 | Day 1 of treatment periods 1, 2, 3, and 4 | Full PK profile 8 blood samples over 24 hours |
| Primary | Peak observed plasma concentration (Cpeak) over time | Days 1, 2, and 7 of treatment periods 1-3; Days 1, 2, 7, and 14 of treatment period 4, sparse blood sampling at 30 min and 1 hour post dose | |
| Primary | Trough observed plasma concentration (Cpredose) over time | Days 1, 2 and 7 of treatment periods 1-3, Days 1, 2, 7 and 14 of treatment period 4, sparse sampling at pre-dose | |
| Secondary | Changes from baseline in sweat chloride concentration | From baseline to Day 7 of treatment periods 1-3, and Days 7 and 14 of treatment period 4 | |
| Secondary | Changes from baseline in percent predicted forced expiratory volume (ppFEV1) | From baseline to Day 7 of treatment periods 1-3, and Days 7 and 14 of treatment period 4 | |
| Secondary | Changes from baseline in percent predicted forced vital capacity (ppFVC) | From baseline to Day 7 of treatment periods 1-3, and Days 7 and 14 of treatment period 4 | |
| Secondary | Changes from baseline in percent predicted forced expiratory flow at 25-75% (ppFEF25-75) | From baseline to Day 7 of treatment periods 1-3, and Days 7 and 14 of treatment period 4 |
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT04135495
GET https://conductscience.org/api/trials/v1/NCT04135495/registered