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Last Updated: May 17, 2022

CLINICAL TRIALS PROFILE FOR COMPOUND 65


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505(b)(2) Clinical Trials for Compound 65

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00009542 ↗ Effects of Kava on the Body's Elimination of Caffeine and Dextromethorphan Completed National Institutes of Health Clinical Center (CC) Phase 4 2001-01-01 This study will examine how kava-a widely used herbal remedy-may affect the body's elimination of other medicines. Many people take kava to reduce anxiety or cause sedation. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a result, information has not been collected on possible interactions between kava and other medications. This study will look at how kava affects the elimination of caffeine-a compound commonly found in chocolate, coffee, tea and soft drinks-and dextromethorphan-an OTC cough suppressant. Normal healthy volunteers 21 years of age or older may be eligible for this 30-day study. Candidates will provide a medical history and undergo a physical examination and routine blood tests. Women of childbearing age will have a urine pregnancy test. Study participants will not drink alcoholic beverages or take any medications (except those given in the study) for 2 weeks prior to the study and throughout its duration. In addition, they will abstain from caffeine, grapefruit and grapefruit juice and charbroiled foods for at least 72 hours before and throughout each study day that urine is collected. On day 1 of the study, study subjects will take one dose each of caffeine and dextromethorphan at 4:00 P.M.. They will empty their bladder before the dosing and then collect all their urine after the dosing for the rest of the day and including the next mornings first urine. They will bring the urine samples to the Clinical Center when the collection is complete. This procedure will be repeated 1 week later (study day 8). After the second urine collection is completed, subjects will take 200 milligrams of kava 3 times a day for 21 days. On study day 29 (after 21 days of kava), subjects will repeat the dextromethorphan and caffeine dosing and urine collection described above, while continuing to take kava. Subjects will have an electroencephalograph (EEG) done before starting kava and again at the end of kava (study day 30). For this procedure, several electrodes (metal cups attached to wires) are secured to the scalp with a glue-like substance. A conductive gel fills the space between the electrode and the scalp to ensure good contact. The electrodes will remain in place for about 2 hours and then removed. The subject lies quietly on a bed during the EEG recording. Participation in the study will end with another physical examination and blood tests following the second EEG and urine collection.
OTC NCT00214877 ↗ Methylene Blue for Cognitive Dysfunction in Bipolar Disorder Completed Stanley Medical Research Institute Phase 3 2003-11-01 While many bipolar patients treated with mood stabilizing medications experience improvement in their symptoms, some continue to have ongoing difficulties with concentration and memory. The purpose of this study is to look at whether these symptoms can be improved by adding the compound methylene blue to the treatment plan of patients who are already taking lamotrigine. Methylene blue is an available 'over the counter medication' in Canada. It has been studied in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies done in bipolar disorder report that methylene blue has had positive effects on both cognition and mood. It is important to do further research in this area as we know that, for patients who continue to have ongoing cognitive difficulties, there is no recognized standard of care for bipolar patients who experience these type of deficits.
OTC NCT00214877 ↗ Methylene Blue for Cognitive Dysfunction in Bipolar Disorder Completed Nova Scotia Health Authority Phase 3 2003-11-01 While many bipolar patients treated with mood stabilizing medications experience improvement in their symptoms, some continue to have ongoing difficulties with concentration and memory. The purpose of this study is to look at whether these symptoms can be improved by adding the compound methylene blue to the treatment plan of patients who are already taking lamotrigine. Methylene blue is an available 'over the counter medication' in Canada. It has been studied in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies done in bipolar disorder report that methylene blue has had positive effects on both cognition and mood. It is important to do further research in this area as we know that, for patients who continue to have ongoing cognitive difficulties, there is no recognized standard of care for bipolar patients who experience these type of deficits.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Compound 65

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000628 ↗ A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 Part 1: To study the potential safety and pharmacokinetic (blood level) effects of zidovudine (AZT) on L-697,661; to obtain additional pharmacokinetic information in humans with L-697,661; to study the effect of L-697,661 on hepatic enzyme induction. Part 2: To begin a study of the antiviral activity of L-697,661. L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.
NCT00000628 ↗ A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine Completed Merck Sharp & Dohme Corp. Phase 1 1969-12-31 Part 1: To study the potential safety and pharmacokinetic (blood level) effects of zidovudine (AZT) on L-697,661; to obtain additional pharmacokinetic information in humans with L-697,661; to study the effect of L-697,661 on hepatic enzyme induction. Part 2: To begin a study of the antiviral activity of L-697,661. L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.
NCT00000675 ↗ A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4 Immunoglobulin (rCd4-IgG) Administered by Intravenous Bolus in Patients With AIDS and AIDS Related Complex Completed Genentech, Inc. Phase 1 1969-12-31 To study the safety and pharmacokinetics (blood levels) of recombinant human CD4 immunoglobulin (rCd4-IgG) in patients with AIDS or AIDS related complex (ARC) who have failed or declined therapy with zidovudine (AZT). An additional goal of the study is to obtain a preliminary indication of the antiviral effects of Cd4-IgG in patients with AIDS or ARC. Other approaches in addition to existing treatment of HIV infection need to be evaluated. One approach may be to block HIV infection by interrupting the assembly of the virus within the cell or the budding of virus from the membrane of the infected cell. In addition, blocking the attachment of HIV to its cellular receptor may offer another point of attack. HIV binds to the CD4 receptor on the target T4 lymphocyte and the envelope glycoprotein of the virus (gp120) is capable of high affinity binding to CD4. Any agent that prevents the attachment of gp120 to the CD4 receptor should be able to block virus transmission and spread. Recently, scientists have succeeded in producing highly purified recombinant soluble human CD4. Recombinant CD4 is capable of binding to HIV envelope protein (gp120) and inhibiting HIV infectivity in test tube studies. Potential therapeutic benefit in patients with HIV infection could be derived from either or both of these biologic effects. In order to extend the length of time that rCD4 stays in the body, the compound has been modified by combining it with a human immunoglobulin of the IgG1 class (IgG).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Compound 65

Condition Name

Condition Name for Compound 65
Intervention Trials
Healthy 75
Schizophrenia 41
Breast Cancer 24
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Condition MeSH

Condition MeSH for Compound 65
Intervention Trials
Neoplasms 48
Diabetes Mellitus 44
Schizophrenia 43
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Clinical Trial Locations for Compound 65

Trials by Country

Trials by Country for Compound 65
Location Trials
China 285
Australia 98
Italy 88
France 66
Netherlands 63
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Trials by US State

Trials by US State for Compound 65
Location Trials
California 185
New York 148
Texas 136
Maryland 122
Florida 119
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Clinical Trial Progress for Compound 65

Clinical Trial Phase

Clinical Trial Phase for Compound 65
Clinical Trial Phase Trials
Phase 4 154
Phase 3 141
Phase 2/Phase 3 50
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Clinical Trial Status

Clinical Trial Status for Compound 65
Clinical Trial Phase Trials
Completed 914
Recruiting 196
Unknown status 151
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Clinical Trial Sponsors for Compound 65

Sponsor Name

Sponsor Name for Compound 65
Sponsor Trials
GlaxoSmithKline 75
Pfizer 61
National Cancer Institute (NCI) 45
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Sponsor Type

Sponsor Type for Compound 65
Sponsor Trials
Other 1517
Industry 898
NIH 172
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