Enrolled subjects will be screened and randomized into the three study arms in a 1:1:1 ratio. 50 subjects with constipation-predominant irritable bowel syndrome (IBS-C) will be administered a 12-week course of lovastatin (21 mg PO QD). Study activities will be the same across all three arms.

Enrolled subjects will be screened and randomized into the three study arms in a 1:1:1 ratio. 50 subjects with constipation-predominant irritable bowel syndrome (IBS-C) will be administered a 12-week course of lovastatin (42 mg PO QD). Study activities will be the same across all three arms.

Enrolled subjects will be screened and randomized into the three study arms in a 1:1:1 ratio. 50 subjects with constipation-predominant irritable bowel syndrome (IBS-C) will be administered a 12-week course of placebo. Study activities will be the same across all three arms.

Irritable Bowel Syndrome With Constipation

21 mg lovastatin will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels.

SYN-010 21 mg

42 mg lovastatin will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels.

SYN-010 42 mg

A placebo will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels.

Placebo

Cedars-Sinai Medical Center

Efficacy and Safety of SYN-010 in IBS-C

Evaluation of the Efficacy and Safety of Single, Daily Oral Doses of SYN-010 Compared to Placebo in Adult Patients With Irritable Bowel Syndrome With Constipation (EASE-DO)

Subjects will record their daily bowel movements throughout the duration of the study. Change in weekly average number of CSBMs will be evaluated by comparing reported values pre- and post-treatment.

An overall 12-week responder is defined as a patient with a weekly response in at least 50% of the weeks of treatment (6 of 12 weeks). A weekly response is defined as a decrease in the patient's weekly average score for worst abdominal pain in the past 24 hours of at least 30% compared to baseline and a stool frequency increase of 1 or more CSBMs per week compared with baseline.

An overall stool frequency responder is defined as a patient with a weekly stool frequency response in at least 50% of the weeks of treatment (6 of 12 weeks). A weekly stool frequency response is defined as a stool frequency increase of 1 or more CSBMs per week compared with baseline, with abdominal pain unchanged or improved compared with baseline.

An overall abdominal pain intensity responder is defined as a patient with a weekly abdominal pain intensity response in at least 50% of the weeks of treatment (6 of 12 weeks). A weekly response abdominal pain intensity response is defined as a decrease in the patient's weekly average score for worst abdominal pain in the past 24 hours of at least 30% compared to baseline, with stool frequency unchanged or improved compared with baseline.

An overall bloating responder is defined as a patient with a weekly bloating response in at least 50% of the weeks of treatment (6 of 12 weeks). A weekly bloating response is defined as a weekly average bloating score of at least 30% improvement compared to baseline, with stool frequency unchanged or improved compared with baseline.

Subjects will record their use of rescue medication throughout the study period. Proportion of patients using rescue medication after completing the 12-week course of treatment will be compared to those reporting usage at baseline screening period.

Outcome will be assessed by evaluating proportion of patients reporting adequate relief pre- and post-treatment on validated questionnaire.

Change in exhaled methane level as a potential predictor of constipation improvement will be evaluated by comparing lactulose breath tests pre- and post-treatment.

Change in exhaled methane level as a potential predictor of constipation improvement will be evaluated by comparing single-point breath tests pre- and post-treatment.

Ali Rezaie

Director of GI Motility

Synthetic Biologics Inc.

This blend contains Ginko at 120 mg/day and Cistanche at 300 mg/day

This blend contains Ginko at 180 mg/day and Cistanche at 450 mg/day

Mental Fatigue

Fatigue

Chronic Fatigue Syndrome

Experimental: Nutrilite® Low dose

Experimental: Nutrilite® High dose

Placebo Comparator: Placebo

Effect of Ginko and Cistanche Against Fatigue Symptoms

A 60-Day Clinical Study to Evaluate Nutrilite Ginko Biloba Cistanche Tablets in Relieving the Symptoms of Chronic Fatigue Syndromes Compared to Negative Control

Access Business Group

Sinphar Pharmaceutical Co., Ltd

SPRIM China (Shanghai) Consulting Co., LTD.

Fudan University

Pravastatin 20mg tablet (age 8-13 years), 40mg tablet (>14 years); 1 time dose given per oral at at the start of the study day.

Simvastatin 10mg tablet (ages 8-13 years), 20mg tablet (>14 years); 1 time dose given per oral at the start of the study day.

Drug Distribution

Pravastatin

Simvastatin

Children's Mercy Hospital

Statin Distribution

Pharmacokinetics of Pravastatin and Simvastatin in Pediatric Dyslipidemia Patients: Clinical Impact of Genetic Variation in Statin Disposition

Jon Wagner

Children's Mercy Hospital Kansas City

American Heart Association

80 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48)PO, DAILY

160 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, DAILY

320 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, DAILY

640 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, DAILY

1280 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, DAILY

2560 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

18 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

36 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

72 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

144 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

288 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

576 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

750mg/m2 PO Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

1000mg/m2 PO Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

1280 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

Advanced Solid Tumors

Lymphomas

CZ48 will be administered in successive cohorts of 1 patient per participating site until hints of toxicity (grade 2 or worse adverse events related to the drug) are observed. Then cohort of 3+3 patients will be treated. CZ48 will be administered orally daily for 3 weeks followed by a 1 week rest. (1 course = 4 weeks). No pre-medications will be administered. Patients will be asked to drink 2 liters of fluid daily to flush the bladder.

Camptothecin-20-O-Propionate Hydrate (CZ48)

University of Texas Health Sciences Center

lactone/driska

Efficacy and Safety of SYN-010 in IBS-C

Effect of Ginko and Cistanche Against Fatigue Symptoms

Statin Distribution

Phase I and Pharmacology Study of Camptothecin-20-O-Propionate Hydrate (CZ48) in Patients With Solid Tumors or Lymphoma

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