CLINICAL TRIALS PROFILE FOR HYDROXYPROPYL CELLULOSE
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All Clinical Trials for hydroxypropyl cellulose
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01231568 ↗ | An Open Label Study to Examine the Effects of a High-Fat Meal and Particle Size on the Pharmacokinetics of Orally Administered GSK2118436 in Subjects With BRAF Mutation Positive Tumor | Completed | GlaxoSmithKline | Phase 1 | 2010-10-21 | The study is designed to evaluate the effects of a high fat meal on the pharmacokinetics of 150 mg of GSK2118436, as well as the effects of particle size on the relative bioavailability of GSK2118436. |
| NCT01324141 ↗ | Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer | Terminated | National Cancer Institute (NCI) | Phase 1 | 2011-03-18 | Background: - Radiation and chemotherapy treatments for anal cancer can cause irritation of the skin that can lead to redness and tenderness, and in some cases can be so severe that it results in blistering or peeling of the skin during treatment. These conditions cause discomfort and may require breaks from radiation treatment. Researchers are interested in determining whether MTS-01, a drug that protects cells and tissues from the effects of radiation, can be given before radiation treatment to prevent these side effects and reduce the irritation of the skin during chemotherapy and radiation for anal cancer. Objectives: - To determine the safety and effectiveness of topical MTS-01 given before radiation in the groin and gluteal cleft of patients receiving combined radiation and chemotherapy for anal cancer. Eligibility: - Individuals at least 18 years of age who have been diagnosed with cancer of the anal canal and are eligible to receive radiation and chemotherapy treatments. Design: - Participants will be screened with a physical examination, medical history, blood tests, imaging studies and physical examination of the anal canal, and biopsies as needed to evaluate eligibility for treatment. - Participants will be scheduled for radiation and chemotherapy treatments on the following schedule: - Radiation given 5 days per week for 6 weeks, with topical MTS-01 treatment on the skin in the groin areas and between the buttocks before each treatment - Mitomycin C given intravenously on days 1 and 29 of treatment - 5-Fluorouracil given intravenously over 4 days (first week and fifth week) during radiation treatment - Participants will be monitored throughout the treatment for side effects, with photographs of the treatment area and frequent blood tests. - Following the end of radiation, participants will have followup visits for 1 year with blood tests and imaging studies to evaluate the response to treatment. |
| NCT01989663 ↗ | A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1 | 2013-11-01 | This is a Phase I, five arm, single site, randomized, double blind placebo-controlled trial assessing the safety of tenofovir vaginal gel and film formulations. HIV negative women will be randomized to gel or film, tenofovir or placebo. This study will provide additional information in the evaluation of vaginal films containing microbial agents in humans. In addition to safety, the efficacy of these formulations against HIV in an ex vivo biopsy challenge model will be compared. This study is the first study assessing the safety of tenofovir film in humans. Tenofovir film is formulated in a cellulose based vaginal film containing hydroxypropyl methyl cellulose (HPMC) E5 (5 cp), hydroxyethyl cellulose (HEC), Sodium Carboxymethylcellulose (NaCMC), and glycerin. The excipients of the film have documented safety in other clinical settings. While the tenofovir film has not been studied extensively in preclinical studies, there are favorable safety data from the macaque study and a substantial body of research with tenofovir gel. It is appropriate to advance the tenofovir film products into a clinical trial for the following reasons: - No safety concerns were note in the tenofovir film macaque trial. - The toxicity of tenofovir administered vaginally has been studied extensively. No clinically significant toxicity associated with this route of administration has been observed to date. - All of the active ingredients of the tenofovir film have been tested in pre-clinical toxicity studies; therefore, the influence of these ingredients on the toxicity profile of tenofovir has been adequately evaluated and has been shown to result in no local or systemic effects. - The individual components of the tenofovir film have been adequately evaluated and have been shown to be safe. |
| NCT01989663 ↗ | A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04 | Completed | National Institutes of Health (NIH) | Phase 1 | 2013-11-01 | This is a Phase I, five arm, single site, randomized, double blind placebo-controlled trial assessing the safety of tenofovir vaginal gel and film formulations. HIV negative women will be randomized to gel or film, tenofovir or placebo. This study will provide additional information in the evaluation of vaginal films containing microbial agents in humans. In addition to safety, the efficacy of these formulations against HIV in an ex vivo biopsy challenge model will be compared. This study is the first study assessing the safety of tenofovir film in humans. Tenofovir film is formulated in a cellulose based vaginal film containing hydroxypropyl methyl cellulose (HPMC) E5 (5 cp), hydroxyethyl cellulose (HEC), Sodium Carboxymethylcellulose (NaCMC), and glycerin. The excipients of the film have documented safety in other clinical settings. While the tenofovir film has not been studied extensively in preclinical studies, there are favorable safety data from the macaque study and a substantial body of research with tenofovir gel. It is appropriate to advance the tenofovir film products into a clinical trial for the following reasons: - No safety concerns were note in the tenofovir film macaque trial. - The toxicity of tenofovir administered vaginally has been studied extensively. No clinically significant toxicity associated with this route of administration has been observed to date. - All of the active ingredients of the tenofovir film have been tested in pre-clinical toxicity studies; therefore, the influence of these ingredients on the toxicity profile of tenofovir has been adequately evaluated and has been shown to result in no local or systemic effects. - The individual components of the tenofovir film have been adequately evaluated and have been shown to be safe. |
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