Autopsy report · NCT04080895

Pharmacokinetic Study of Artemether-lumefantrine and Amodiaquine in Healthy Subjects

“The decision was made due to the expired investigational drug and regulatory changes by the Thai FDA, along with increased importation costs. The research team and investigational drug sponsor agreed to seek approval for early project termination.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 3 years 5 months before it started.
• Ran for about 2 years 5 months before it stopped.
• 8 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 1

Sponsor

University of Oxford

Sponsor type

University, hospital or other

Conditions

Pharmacokinetic; Healthy; Drug Combination

Interventions

Artemether-lumefantrine; Amodiaquine; Artemether-lumefantrine; Artemether-lumefantrine + Amodiaquine

Participants

8

Sites

1

Countries

Thailand

Trials that died the same way

• Study of Magrolimab Combinations in Patients With Relapsed/Refractory Multiple Myeloma
  “This study was terminated early due to the Sponsor's decision to discontinue development of the investigational drug and close the program.” (71% match in meaning)
• A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma
  “The study was terminated due to regulatory approval of newer therapeutic options and slower than anticipated accrual.” (68% match in meaning)
• Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C
  “It was decided by Sponsor on 13 January 2014 to terminate study early at primary efficacy endpoint as part of a decision to modify drug development plan.” (67% match in meaning)
• Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio
  “The study has been terminated based on Sponsor decision. This decision is not related to any safety concerns associated with the investigational products. It is related to the fact that study will be not required for product dossier submission.” (64% match in meaning)
• CIVO Intratumoural Microdosing of Anti-Cancer Therapies in Australia
  “Termination by pharmaceutical sponsor” (64% 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.