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Long-Term Safety Study of Tafenoquine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03320174
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
60 Degrees Pharmaceuticals LLC

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Tafenoquine Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Identically matched placebo control.
Primary Purpose: Prevention
Official Title: Single Site, Randomized, Double Blind, Placebo-Controlled Study to Assess the Long-Term Safety of Tafenoquine
Actual Study Start Date : October 5, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
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
Drug: Tafenoquine
Tafenoquine 200mg

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




Primary Outcome Measures :
  1. Proportion of Subjects with Spectral Domain Optical Coherence Tomography (SD-OCT) and Quantitative Fundus Auto Fluorescence (qFAF) with clinically significant changes compared with baseline. [ Time Frame: After 12 months of exposure to study drug ]

Secondary Outcome Measures :
  1. The incidence, severity and relationship to the investigational medicinal product of AEs [ Time Frame: After 12 months of exposure to study drug ]
  2. 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 [ Time Frame: After 12 months of exposure to study drug ]
  3. Proportion of participants with ellipsoid or interdigitating zone disruption [ Time Frame: After 12 months of exposure to study drug ]
  4. Mean change from baseline in Best Corrected Visual Acuity [ Time Frame: After 12 months of exposure to study drug ]
  5. Proportion of participants with corneal deposits from slit lamp examination of the corneal epithelium [ Time Frame: After 12 months of exposure to study drug ]
  6. Proportion of participants with new abnormalities compared with baseline observed with color retinal digital photography [ Time Frame: After 12 months of exposure to study drug ]
  7. Proportion of participants with new abnormalities compared with baseline observed with multifocal electroretinography [ Time Frame: After 12 months of exposure to study drug ]
  8. Proportion of participants with new abnormalities compared with baseline observed with microperimetry [ Time Frame: After 12 months of exposure to study drug ]
  9. 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) [ Time Frame: After 12 months of exposure to study drug ]
  10. Proportion of participants who develop a color deficiency using the Farnsworth-Munsell 100 (FM-100) hue test [ Time Frame: After 12 months of exposure to study drug ]
  11. Proportion of participants who develop a loss of 0.12 or greater logarithm of contrast sensitivity (logCS) on the Mars letter contrast sensitivity test [ Time Frame: After 12 months of exposure to study drug ]
  12. Proportion of participants with any new anomaly on the backlit ETDRS chart [ Time Frame: After 12 months of exposure to study drug ]
  13. 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 [ Time Frame: After 12 months of exposure to study drug ]
  14. Proportion of participants with an AE of dizziness or vertigo and severity as assessed by the Dizziness Handicap Inventory [ Time Frame: After 12 months of exposure to study drug ]
  15. Mean change from baseline visual analog scale score (1-100) in Getting to Sleep (GTS) as assessed by the Leeds Sleep Evaluation Questionnaire (LSEQ). [ Time Frame: After 12 months of exposure to study drug ]
  16. Mean change from baseline visual analog scale score (1-100) Quality of Sleep (QOS) as assessed by the Leeds Sleep Evaluation Questionnaire (LSEQ). [ Time Frame: After 12 months of exposure to study drug ]
  17. Mean change from baseline visual analog scale score (1-100) Awake Following Sleep (AFS) as assessed by the Leeds Sleep Evaluation Questionnaire (LSEQ). [ Time Frame: After 12 months of exposure to study drug ]
  18. Mean change from baseline visual analog scale score (1-100) Behavior Following Wakening (BFW) as assessed by the Leeds Sleep Evaluation Questionnaire (LSEQ). [ Time Frame: After 12 months of exposure to study drug ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Main Inclusion Criteria:

  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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320174


Locations
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United States, Colorado
Retina Consultants of Southern Colorado Recruiting
Colorado Springs, Colorado, United States, 80909
Contact: Pamela Berry    719-473-9595 ext 130    pberry@coloradoretina.com   
Principal Investigator: Mark Chittum, MD         
United States, Texas
Valley Retina Institute Recruiting
McAllen, Texas, United States, 78503
Contact: Yesenia Salinas    956-631-8875    vgonzalez@vritx.com   
Principal Investigator: Victor Gonzalez, MD         
Australia, Western Australia
Linear Clinical Research Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Shashi Aggarwal, PhD    1300 546 327    enquiries@linear.org.au   
Principal Investigator: Fred Chen, PhD, FRANZCO         
Sponsors and Collaborators
60 Degrees Pharmaceuticals LLC
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Responsible Party: 60 Degrees Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT03320174    
Other Study ID Numbers: 60PH04
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by 60 Degrees Pharmaceuticals LLC:
tafenoquine
australia
Additional relevant MeSH terms:
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Tafenoquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents