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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03320174




Registration number
NCT03320174
Ethics application status
Date submitted
18/10/2017
Date registered
25/10/2017
Date last updated
11/01/2019

Titles & IDs
Public title
Long-Term Safety Study of Tafenoquine
Scientific title
Single Site, Randomized, Double Blind, Placebo-Controlled Study to Assess the Long-Term Safety of Tafenoquine
Secondary ID [1] 0 0
60PH04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tafenoquine
Other interventions - Placebo

Active Comparator: Tafenoquine 200 mg (2 x 100 mg tablets) - Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks

Placebo Comparator: Placebo - Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks


Treatment: Drugs: Tafenoquine
Tafenoquine 200mg

Other interventions: Placebo
Placebo

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Subjects with Spectral Domain Optical Coherence Tomography (SD-OCT) and Quantitative Fundus Auto Fluorescence (qFAF) with clinically significant changes compared with baseline.
Timepoint [1] 0 0
After 12 months of exposure to study drug
Secondary outcome [1] 0 0
The incidence, severity and relationship to the investigational medicinal product of AEs
Timepoint [1] 0 0
After 12 months of exposure to study drug
Secondary outcome [2] 0 0
Mean change from baseline in key SD OCT parameters including central subfield thickness, total macular volume, and parafoveal (inner ring of Early Treatment Diabetic Retinopathy Study, and retinal thickness
Timepoint [2] 0 0
After 12 months of exposure to study drug
Secondary outcome [3] 0 0
Proportion of participants with ellipsoid or interdigitating zone disruption
Timepoint [3] 0 0
After 12 months of exposure to study drug
Secondary outcome [4] 0 0
Mean change from baseline in Best Corrected Visual Acuity
Timepoint [4] 0 0
After 12 months of exposure to study drug
Secondary outcome [5] 0 0
Proportion of participants with corneal deposits from slit lamp examination of the corneal epithelium
Timepoint [5] 0 0
After 12 months of exposure to study drug
Secondary outcome [6] 0 0
Proportion of participants with new abnormalities compared with baseline observed with color retinal digital photography
Timepoint [6] 0 0
After 12 months of exposure to study drug
Secondary outcome [7] 0 0
Proportion of participants with new abnormalities compared with baseline observed with multifocal electroretinography
Timepoint [7] 0 0
After 12 months of exposure to study drug
Secondary outcome [8] 0 0
Proportion of participants with new abnormalities compared with baseline observed with microperimetry
Timepoint [8] 0 0
After 12 months of exposure to study drug
Secondary outcome [9] 0 0
Proportion of participants with any clinically significant change in ETDRS BCVA (defined as >15 letter change [= 3 lines] of change in ETDRS BCVA at 4 meters)
Timepoint [9] 0 0
After 12 months of exposure to study drug
Secondary outcome [10] 0 0
Proportion of participants who develop a color deficiency using the Farnsworth-Munsell 100 (FM-100) hue test
Timepoint [10] 0 0
After 12 months of exposure to study drug
Secondary outcome [11] 0 0
Proportion of participants who develop a loss of 0.12 or greater logarithm of contrast sensitivity (logCS) on the Mars letter contrast sensitivity test
Timepoint [11] 0 0
After 12 months of exposure to study drug
Secondary outcome [12] 0 0
Proportion of participants with any new anomaly on the backlit ETDRS chart
Timepoint [12] 0 0
After 12 months of exposure to study drug
Secondary outcome [13] 0 0
Proportion of participants who develop a psychiatric disorder in accordance with DSM-5 as assessed with the Mini International Neuropsychiatric Interview (M.I.N.I.) 7.0.2 assessment questionnaire
Timepoint [13] 0 0
After 12 months of exposure to study drug
Secondary outcome [14] 0 0
Proportion of participants with an AE of dizziness or vertigo and severity as assessed by the Dizziness Handicap Inventory
Timepoint [14] 0 0
After 12 months of exposure to study drug
Secondary outcome [15] 0 0
Mean change from baseline visual analog scale score (1-100) in Getting to Sleep (GTS) as assessed by the Leeds Sleep Evaluation Questionnaire (LSEQ).
Timepoint [15] 0 0
After 12 months of exposure to study drug
Secondary outcome [16] 0 0
Mean change from baseline visual analog scale score (1-100) Quality of Sleep (QOS) as assessed by the Leeds Sleep Evaluation Questionnaire (LSEQ).
Timepoint [16] 0 0
After 12 months of exposure to study drug
Secondary outcome [17] 0 0
Mean change from baseline visual analog scale score (1-100) Awake Following Sleep (AFS) as assessed by the Leeds Sleep Evaluation Questionnaire (LSEQ).
Timepoint [17] 0 0
After 12 months of exposure to study drug
Secondary outcome [18] 0 0
Mean change from baseline visual analog scale score (1-100) Behavior Following Wakening (BFW) as assessed by the Leeds Sleep Evaluation Questionnaire (LSEQ).
Timepoint [18] 0 0
After 12 months of exposure to study drug

Eligibility
Key inclusion criteria
Main

1. Completion of the written informed consent process (signed).

2. Male or female age 18 to 55 years inclusive, in good health as assessed by the
Investigator.

3. Normal G6PD enzyme activity levels as defined by the parameters of the specific G6PD
test employed at the local laboratory.

4. Negative HBsAg and HCV, HIV-1, HIV-2 antibody screen at the screening visit.

5. Negative serum pregnancy test.

6. Use acceptable method of birth control.

7. Hematology, biochemistry and urinalysis results at screening that are within the local
laboratory reference range or, if outside the range, not clinically significant as
judged by the Investigator in accordance with approved clinically acceptable
laboratory ranges, documented prior to study start.

8. Willing and able to comply with all scheduled visits, treatment plan, laboratory
tests, and other study procedures.

Main
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of allergy or intolerance to tafenoquine, primaquine or any excipients.

2. History of thalassemia or current or past history of methemoglobinemia or
methemoglobin >2% at screening.

3. History of eye disease or surgery

4. Having previously received hydroxychloroquine for skin conditions or rheumatological
diseases, chloroquine for malaria, tamoxifen, amiodarone or other drugs that may
affect the optic nerve/retina/cornea within 30 days or 5 half-lives (whichever is
longer) of study start. There are no travel restrictions, but the choice of concurrent
anti-malarial must be atovaquone-proguanil if the participant chooses to take a
registered antimalarial drug while travelling.

5. Any current diagnosis of Axis I psychiatric disorders

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
60 Degrees Pharmaceuticals LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This randomized, double-blind, placebo controlled study will involve 600 healthy
(Glucose-6-Phosphate Dehydrogenase [G6PD] normal) volunteers. Participants who meet the
eligibility criteria will be randomized (ratio 1:1) to receive a loading dose of either
tafenoquine 200 mg (2 x 100 mg tablets) or placebo daily for three consecutive days, followed
by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks, with safety
follow-up visits at Weeks 4, 12, 24, and 52. All participants will return to the clinic at
Week 64 for an end of study visit. If the participant has an ongoing AE at the Week 64 visit
will continue to be assessed for up to 3 more times at approximately 12-week intervals or
until resolution or stabilization of the AE whichever is earlier.
Trial website
https://clinicaltrials.gov/show/NCT03320174
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03320174