Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of SP-333 Tablets in Healthy Adult Subjects

Completed · Phase 1

Conditions studied: Exposure

In brief

This is a randomized, phase 1, single-blind, placebo-controlled, randomized, sequential, escalating, single-dose, study designed to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) properties of orally administered SP-333 tablets.

Key facts

Study ID

NCT01705938

Run by

Bausch Health Americas, Inc.

People needed

56

Starts

2012-10-01

Expected to finish

2012-12-01

Last updated by the study team

2019-05-24

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female subjects between 18 and 55 years old
• Body weight greater than or equal to 50 kg (110 pounds) and Body Mass Index (BMI) in the range of 18 to 30 kg/ m2
• Medically healthy with no clinically significant findings.
• Subjects must have bowel habits that are considered regular (for this study a minimum of 4 bowel movements a week without laxatives).
• Subject must have had a bowel movement, without laxatives, in the 3 days before administration of study drug.
• Male subjects with female sexual partners of child-bearing potential must agree to use highly effective contraceptive methods during the study.
• Female subjects must be post-menopausal and not pregnant.
• Subjects must understand and agree to comply with the requirements of the study and they must be willing to sign an Informed Consent Form.

You may not qualify if…

• Smokers or users of nicotine products who do not agree to not smoke or use nicotine products during their stay in the CPU.
• Current or history of clinically significant diseases, including gastrointestinal, renal, hepatic, neurologic (e.g., neuropathy), hematologic, endocrine (e.g., diabetes), oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition.
• Presence of any abnormal clinically significant laboratory.
• History of any serious allergic reaction to any medication
• Certain abnormalities of the ECG.
• Participated in a previous clinical study with an investigational product within 30 days of study Participation
• Donated blood, blood components or significant loss of blood within 2 months of dosing
• History of a clinically-significant illness within 4 weeks of dosing
• Special diet, any dietary habits, or restrictions, which, may interfere with conduct of the study or health of the subject within 30 days of dosing
• History of clinically-significant drug or alcohol abuse within 2 years of study participation
• Positive urine screen for prohibited drugs (cocaine, cannabinoids, opiates, barbiturates, amphetamines, benzodiazepines, phencyclidine, propoxyphene).
• History of human immunodeficiency virus (HIV), hepatitis B surface antigen positive (+HBsAg), or hepatitis C antibody positive (+HCVAb).
• History of certain surgeries:
• Gastric bypass surgery or invasive procedure for the treatment of obesity or surgery to remove a segment of the gastrointestinal (GI) tract at any time.
• Patients who have had a gastric band (unless the band has been completely removed for more than 60 days)
• Surgery of the abdomen, pelvis or retroperitoneal structures within six months of study participation.
• Appendectomy,Instrumentation of the bowel, major surgery within 60 days of study participation.
• Female subjects of childbearing potential or who are breastfeeding
• Use of any routine systemic medication, including any over the counter (OTC) medication within 2 weeks of dosing
• Use of herbal products, dietary supplements, vitamins, grapefruit, or grapefruit containing products within 2 weeks of dosing
• Irregular daily bowel habits
• Any other issue which, in the judgment of the investigator, will make the subject ineligible for study participation

Where it is running

• Anaheim Clinical Trials — Anaheim, California, United States

Full record on ClinicalTrials.gov

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