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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01705938
• Date of registration: 08/10/2012
• Prospective Registration: No
• Primary sponsor: Bausch Health Americas, Inc.
• Public title: Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of SP-333 Tablets in Healthy Adult Subjects
• Scientific title: A First In Human, Single Blind, Placebo Controlled, Randomized Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SP-333 Tablets in Healthy Adult Subjects
• Date of first enrolment: October 2012
• Target sample size: 56
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01705938
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: Single (Participant).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Peter Winkle, MD
• Affiliation: Anaheim Clinical Trials

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female subjects between 18 and 55 years old

2. 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

3. Medically healthy with no clinically significant findings.

4. Subjects must have bowel habits that are considered regular (for this study a minimum
of 4 bowel movements a week without laxatives).

5. Subject must have had a bowel movement, without laxatives, in the 3 days before
administration of study drug.

6. Male subjects with female sexual partners of child-bearing potential must agree to use
highly effective contraceptive methods during the study.

7. Female subjects must be post-menopausal and not pregnant.

8. Subjects must understand and agree to comply with the requirements of the study and
they must be willing to sign an Informed Consent Form.

Exclusion Criteria:

1. Smokers or users of nicotine products who do not agree to not smoke or use nicotine
products during their stay in the CPU.

2. 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.

3. Presence of any abnormal clinically significant laboratory.

4. History of any serious allergic reaction to any medication

5. Certain abnormalities of the ECG.

6. Participated in a previous clinical study with an investigational product within 30
days of study Participation

7. Donated blood, blood components or significant loss of blood within 2 months of dosing

8. History of a clinically-significant illness within 4 weeks of dosing

9. 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

10. History of clinically-significant drug or alcohol abuse within 2 years of study
participation

11. Positive urine screen for prohibited drugs (cocaine, cannabinoids, opiates,
barbiturates, amphetamines, benzodiazepines, phencyclidine, propoxyphene).

12. History of human immunodeficiency virus (HIV), hepatitis B surface antigen positive
(+HBsAg), or hepatitis C antibody positive (+HCVAb).

13. 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.

14. Female subjects of childbearing potential or who are breastfeeding

15. Use of any routine systemic medication, including any over the counter (OTC)
medication within 2 weeks of dosing

16. Use of herbal products, dietary supplements, vitamins, grapefruit, or grapefruit
containing products within 2 weeks of dosing

17. Irregular daily bowel habits

18. Any other issue which, in the judgment of the investigator, will make the subject
ineligible for study participation



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Exposure

Intervention(s)

Drug: SP-333

Primary Outcome(s)

Percentage of participants with treatment emergent adverse events as a measure of safety and tolerability [Time Frame: 14 days]

Secondary Outcome(s)

Area under the plasma concentration versus time curve (AUC) of SP-333 following single oral doses of tablets. [Time Frame: 48 hours]

Secondary ID(s)

SP333101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors