A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Participants
Model scores of the 29,894 trials active now.
Model score 3% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-02-04, after 2023-08-04 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-02-04. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: bowelprioracutesurgerypurpose
Phrases that lowered it: healthykgvisitthe pharmacokineticsparticipants -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Sponsor's past termination rate: 5.9% (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 9.7% (lowers risk) · Drug's FDA history
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
-
Drug's FAERS reports before start: 92743 (lowers risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Number of arms: 5 (lowers risk) · Design
-
Blinding: none (lowers risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 76.9% (lowers risk) · Drug's FDA history
-
Maximum age: 55 (lowers risk) · Who can join
-
Design: sequential (lowers risk) · Design
-
Sponsor's past trials: 17 (lowers risk) · Sponsor's track record
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 5 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 55 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 17 (typical: 32)
- Sponsor's past termination rate
- 5.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 92743 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7596 (typical: 412.5)
- Drug's FAERS reports marked serious
- 76.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- azithromycin, ethambutol
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR206 in Healthy Volunteers NCT03792308 · started 2018 · scored riskier than 4% of active trials completed
- A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR741 in Healthy Volunteers NCT03022175 · started 2016 · scored riskier than 5% of active trials completed
- Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741 NCT03376529 · started 2017 · scored riskier than 0% of active trials completed
- A Study of the Safety, Tolerability, and Pharmacokinetics of SPR720 in Healthy Volunteers NCT03796910 · started 2018 · scored riskier than 7% of active trials completed
- A Study to Assess the Pharmacokinetics of AZD4831 When Administered Alone and in Combination With Itraconazole NCT05236543 · started 2022 · scored riskier than 2% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.