Last updated: 02/21/2024 12:11:04
Evaluation of the sensory profile of pediatric Tafenoquine (TQ) dispersible tablets in adults
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Sensory Evaluation of the Dispersible Formulation of Tafenoquine (SB-252263, WR238605)
Trial description: Infants, children and adolescents account for a significant proportion of Plasmodium vivax (P.vivax) infections worldwide. Tafenoquine dispersible 50 milligram (mg) tablets have been formulated as a potential radical cure for latent liver stage malaria (P.vivax) for the pediatric population (less than 16 years of age). An initial adult sensory test for Tafenoquine concluded that adding sucralose into the formulation could improve the taste of the formulation. This study will aim to investigate possible strategies to mitigate acceptability issues identified in subjects during development. This is an open-label, sensory analysis study, which will be performed with trained adult sensory panellists. This study will investigate if it is possible to use the ‘sip, tip and spit’ methodology to profile the palatability attributes of Tafenoquine compared to placebo and to determine if different concentrations and diluents may potentially improve tolerability. A maximum of 24 and a minimum of 12 subjects will be enrolled into the study and the total duration of the study will be approximately 6 weeks.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of subjects with sensory profile scores of palatability
Timeframe: Week 5
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
0
Primary completion date:
2019-02-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Ivan D. Velez, Tran T. Hien, Justin A. Green, Ana Martin, Hema Sharma, Victoria M. Rousell, John J. Breton, Terry B. Ernest, Katie Rolfe, Maxine Taylor, Khadda Mohamed, Sion W. Jones, Nguyên Hoang Chau, Nhu Thi Hoa, Stephan Duparc, Lionel K. Tan, Navin Goyal. Tafenoquine plus chloroquine for the treatment and relapse prevention of Plasmodium vivax malaria in children. Lancet Child Adolesc Health. 2021; DOI: https://doi.org/10.1016/S2352-4642(21)00328-X.
Medical condition
Malaria
Product
tafenoquine
Collaborators
Not applicable
Study date(s)
April 2019 to May 2019
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- The subject must be employed as members of the GlaxoSmithKline (GSK) consumer health sensory panel (Brentford, United Kingdom).
- The subject must be male or female and greater than or equal to 18 years of age inclusive, at the time of signing the informed consent. Female subjects, a female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies; is not a woman of childbearing potential (WOCBP) or is a WOCBP and using an acceptable contraceptive method during the intervention period (at a minimum until after the last sensory assessment). The clinical unit Cambridge (CUC) physician should evaluate the effectiveness of the contraceptive method in relationship to the first planned sensory assessment. In the event of accidental ingestion of Tafenoquine during the sensory assessments, WOCBP will be advised to continue to use the acceptable contraceptive method for 5 terminal half-lives of Tafenoquine (3 months). A WOCBP must have a negative highly sensitive pregnancy test (urine) at screening. In the event of accidental ingestion of Tafenoquine during the sensory assessments, it will be recommended that the sensory laboratory team are informed immediately and the subject contact the CUC for an additional pregnancy test.
- The subject has active mouth ulcers or bleeding gums within the previous 24 hours. At the start of each assessment day, panellists will be asked to confirm that they do not have any active mouth ulcers or bleeding gums within the previous 24 hours.
- The subject is taking any concomitant medications which in the opinion of the CUC physician should exclude them from taking part in the study (with the exception of paracetmol and oral contraception for WOCBP). At the start of each assessment day, panellists will be asked to confirm that they have not taken any repeat over the counter or prescribed medication since the last study visit.
Inclusion and exclusion criteria
Inclusion criteria:
- The subject must be employed as members of the GlaxoSmithKline (GSK) consumer health sensory panel (Brentford, United Kingdom).
- The subject must be male or female and greater than or equal to 18 years of age inclusive, at the time of signing the informed consent. Female subjects, a female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies; is not a woman of childbearing potential (WOCBP) or is a WOCBP and using an acceptable contraceptive method during the intervention period (at a minimum until after the last sensory assessment). The clinical unit Cambridge (CUC) physician should evaluate the effectiveness of the contraceptive method in relationship to the first planned sensory assessment. In the event of accidental ingestion of Tafenoquine during the sensory assessments, WOCBP will be advised to continue to use the acceptable contraceptive method for 5 terminal half-lives of Tafenoquine (3 months). A WOCBP must have a negative highly sensitive pregnancy test (urine) at screening. In the event of accidental ingestion of Tafenoquine during the sensory assessments, it will be recommended that the sensory laboratory team are informed immediately and the subject contact the CUC for an additional pregnancy test.
- The subject must have a normal quantitative glucose-6-phosphate dehydrogenase (G6PD) result based on the reference laboratory ranges.
- The subject must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria:
- The subject has active mouth ulcers or bleeding gums within the previous 24 hours. At the start of each assessment day, panellists will be asked to confirm that they do not have any active mouth ulcers or bleeding gums within the previous 24 hours.
- The subject is taking any concomitant medications which in the opinion of the CUC physician should exclude them from taking part in the study (with the exception of paracetmol and oral contraception for WOCBP). At the start of each assessment day, panellists will be asked to confirm that they have not taken any repeat over the counter or prescribed medication since the last study visit.
Trial location(s)
Study documents
Protocol
Available language(s): English
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
2019-02-05
Actual study completion date
2019-02-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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