Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03691779) looked at a combination medicine made up of three components — elexacaftor, tezacaftor, and ivacaftor (referred to together as ELX/TEZ/IVA) — and was run in two separate parts. Part A enrolled 16 participants and focused on measuring how the medicine and its breakdown products moved through the body over a 15-day period, including how much of the medicine reached the bloodstream and how it was processed. Part B enrolled 66 participants (64 of whom completed it) and ran for 24 weeks, with its main focus on tracking unwanted or unexpected health events that occurred while taking the medicine. The reported data shows that in Part A, the highest recorded levels of the three active components in the blood (a measure called peak concentration) were 6.13, 6.93, and 1.01 micrograms per millilitre respectively. The levels present in the blood just before each dose (a measure of how much remained overnight) were 2.86, 1.06, and 0.297 micrograms per millilitre. A measure of total drug exposure over a 24-hour period came in at 107, 58.4, and 8.12 hour-micrograms per millilitre for each component. Similar blood-level figures were also reported for the breakdown products the body creates from each component. For Part B, the reported data shows that 65 out of 66 participants experienced at least one treatment-emergent adverse event (an unwanted health event that occurred after starting the medicine), and 1 participant experienced a serious adverse event. It is worth noting that the data as submitted does not include details about what those adverse events were, how severe they were, or what happened as a result, so those specifics were not reported in the structured results available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 37983082) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Cystic Fibrosis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You carry a specific gene change related to cystic fibrosis called "F508del" — either two copies of it, or one copy alongside certain other gene changes (confirm with trial site)
- Your lung function test result (measuring how much air you can breathe out in one second) is at least 40% of the normal expected level for your age, sex, and height
Who may not be able to join:
- You have significant scarring of the liver, with or without increased blood pressure in the liver's blood vessels
- You currently have a lung infection caused by certain germs known to cause faster decline in lung health (confirm with trial site for specific organisms)
- You have previously received a transplant of a solid organ (such as a kidney, liver, or lung) or of blood/bone marrow cells
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Part A: Maximum Observed Plasma Concentration (Cmax) of ELX, TEZ, and IVA; Part A: Observed Pre-dose Plasma Concentration (Ctrough) of ELX, TEZ, and IVA; Part A: Area Under the Concentration Versus Time Curve From 0 to 24 Hours (AUC0-24h) of ELX, TEZ, and IVA; Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.