Autopsy report · NCT03984812

Evaluation of the Safety, Tolerability and Pharmacokinetics (PK) of GSK3732394 First-Time-in-Human (FTIH) Study

“The study was terminated early (following completion of SAD Cohort 3; 80 mg) based on PK/PD modelling which demonstrated the medicine's intended target profile was not achievable.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 9 months before it stopped.
• 24 participants enrolled.
• Results were posted on the registry 1 year 1 month after it ended.

Vital statistics

Status

Terminated

Phase

Phase 1

Sponsor

ViiV Healthcare

Sponsor type

Industry

Conditions

HIV Infections

Interventions

GSK3732394; Placebo

Participants

24

Sites

1

Countries

United States

Trials that died the same way

• Study to Evaluate the Safety, Tolerability, PK, and PD of PB2452 With and Without Ticagrelor Pretreatment in Chinese Healthy Volunteers
  “After recruitment of Cohorts 1-4 was completed, Sponsor decided to terminate study, initially due to COVID and then considering that PK data from the dose planned to be tested in Cohort 5 (18000 mg) would be available from the ongoing Phase 3 study.” (65% match in meaning)
• Prevention Trial: Immune-tolerance With Alum-GAD (Diamyd) and Vitamin D3 to Children With Multiple Islet Autoantibodies
  “The study was interrupted early and terminated when only 26 out of 80 patients were enrolled due to new clinical study results indicating that the current study would not be informative.” (63% match in meaning)
• Safety and Efficacy Evaluation of Bosutinib Plus Atezolizumab in Newly Diagnosed Chronic Leukemia Adult Patients
  “The study has been prematurely terminated due to the onset of 2 dose limiting toxicities in 2 patients.” (62% match in meaning)
• A Study Of Safety, Tolerability And Effectiveness Of Recifercept In Children With Achondroplasia
  “The study was terminated due to lack of efficacy at any of the tested doses on 18th November 2022. The decision to terminate the study is not related to a safety concern.” (62% match in meaning)
• Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide
  “The study was terminated prematurely due to low enrollment numbers and the development of better drugs to treat polyps (ie. Biologics) which were not available when the study began.” (61% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.