First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 in Healthy Participants
Model scores of the 29,894 trials active now.
Model score 6% 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 6% of the time (776 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-06-21, after 2021-12-13 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 2023-06-21. 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
-
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: ascendingsafety tolerabilityleukemiabreast cancerlymphoma
Phrases that lowered it: participantshealthybioavailabilityevaluate theto evaluate -
Sponsor's past termination rate: 9.1% (raises risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 18 (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Blinding: double (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor's past trials: 164 (lowers risk) · Sponsor's track record
-
Number of arms: 11 (lowers risk) · Design
-
Drug's FAERS reports marked serious: 92.6% (raises risk) · Drug's FDA history
-
Maximum age: 55 (lowers risk) · Who can join
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
- 11 (typical: 2)
- Allocation
- randomized
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (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
- 164 (typical: 32)
- Sponsor's past termination rate
- 9.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 18 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 23427 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3617 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 21.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, immunology, urogenital
- Drugs matched to FDA substances
- midazolam
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
- First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants NCT05393271 · started 2022 · scored riskier than 7% of active trials completed
- Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults NCT06039579 · started 2023 · scored riskier than 11% of active trials completed
- VH4524184 Proof-of-Concept in Treatment-Naïve Adults Living With HIV-1 NCT06214052 · started 2024 · scored riskier than 12% of active trials completed
- A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1 NCT06061081 · started 2023 · scored riskier than 21% of active trials terminated
- Phase IIa Dose-ranging Study of GSK1349572 in HIV-1 Infected Adults NCT00708110 · started 2008 · scored riskier than 15% 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.