Autopsy report · NCT01953809

A Pharmacokinetics, Pharmacodynamics, and Safety Study of an Oral Contraceptive Containing Norethindrone and Ethinyl Estradiol When Co-administered With GSK1322322 in Healthy Adult Women

“Emerging GSK1322322 pre-clinical data ID'd potentially reactive metabolites previously not seen that changed the risk: benefit profile and led to a termination”

The sponsor’s own words in the registry.

Life of this trial

• Withdrawn before it enrolled anyone. Its dates are the sponsor's plans, not events that happened.

Vital statistics

Status

Withdrawn

Phase

Phase 1

Sponsor

GlaxoSmithKline

Sponsor type

Industry

Conditions

Infections, Bacterial

Interventions

GSK1322322; EE/NE; GSK1322322 Placebo; EE/NE Placebo

Participants

0

Trials that died the same way

• Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918
  “PK results demonstrate low and variable plasma concentrations so that achieving therapeutic concentrations is unlikely.” (56% 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.