Last updated: 11/03/2018 21:35:18
PGx7572: An Exploratory Investigation of CYP2D6 Activity and Efficacy of tafenoquine and primaquine in TAF112582 Part 1
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: PGx7572: An Exploratory Investigation of CYP2D6 Activity and Efficacy of tafenoquine and primaquine in TAF112582 Part 1
Trial description: Tafenoquine (TQ) is an 8-aminoquinoline (8-AQ) drug for the radical cure of Plasmodium vivax malaria , and in Phase III development. It is envisaged that TQ may challenge primaquine (PQ), another 8-AQ, which is the current standard of care. Recently, several publications have indicated that CYP2D6 activity plays a role in PQ efficacy and have suggested that it may also extend to TQ efficacy (Pybus et al, 2013; Bennett et al, 2013, Marcsisin et al 2014). To deternmine the relationship between CYP2D6 enzymatic activity and TQ efficacy, a pharmacogenetic (PGx) analysis was conducted for subjects involved in TAF112582 (Part 1), a double-blind, placebo-controlled dosing ranging study
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The relationship between genetically predicted CYP2D6 activity (Poor Metabolizer [PM], Intermediate Metabolizer [IM] and Extensive Metabolizer [EM]) and TQ and PQ efficacy (relapse-free vs. relapse) in subjects from TAF112582 Part 1
Timeframe: Not Applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Malaria, Vivax
Product
primaquine, tafenoquine
Collaborators
Not applicable
Study date(s)
May 2014 to June 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
- Subjects who provided written informed consent and a DNA sample for pharmacogenetic research, and had clinical phenotypes
- and genotyping data available
- Subject may be removed from analysis if:
- less than 80% of markers are successfully genotyped and if it cannot be concluded that the available genotypes for the subject
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who provided written informed consent and a DNA sample for pharmacogenetic research, and had clinical phenotypes and genotyping data available
Exclusion criteria:
- Subject may be removed from analysis if:
- less than 80% of markers are successfully genotyped and if it cannot be concluded that the available genotypes for the subject are likely to be accurate and of high quality;
- the genotypes for his/her sex chromosome genotypes do not agree with the reported gender;
- potential sample contamination is detected
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2014-05-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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