Effect of a Standard Meal on the Pharmacokinetic Profile of RP-G28 in Healthy Adult Male and Female Subjects

NCT03563846 | Completed Phase 1 FDA Drug

• 1 other identifier: G28-005
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, open-label, 2-period, 2-sequence, crossover study to evaluate the effect of a standard meal on the pharmacokinetic (PK) profile of orally administered RP-G28.

Conditions

Lactose Intolerance

Outcome Measures

Primary Outcomes (1)

• Area under the plasma concentration-time curve from time 0 extrapolated to infinity

  Assess systemic exposure of RP-G28 when administered in the fed and fasted state

  Days 2 and 1 pretreatment; Day 1 post-treatment, Day 1-3 washout, Day 3 and 4 post-treatment

Secondary Outcomes (4)

• Adverse events

  2, 3, 2 and 1 days pretreatment; 1 - 13 days post-treatment

• Serum chemistry

  21 and 3 days pretreatment; day 4 post-treatment

• Hematology

  21 and 3 days pretreatment; day 4 post-treatment

• Urinalysis

  2, 3, 2 and 1 days pretreatment; day 1 and 3 post-treatment

Study Arms (2)

RP-G28 administered in the fasted state

EXPERIMENTAL

RP-G28, 15 g dissolved in water, administered in the fasted state

Drug: RP-G28

RP-G28 administered in the fed state

EXPERIMENTAL

RP-G28, 15 g dissolved in water, administered immediately following the consumption of a standard non-dairy meal

Drug: RP-G28

Interventions

RP-G28 DRUG

RP-G28 is a purified galacto-oligosaccharide (GOS) product

Also known as: galactic-oligosaccharide

RP-G28 administered in the fasted state; RP-G28 administered in the fed state

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female subjects between 18 and 60 years of age
• Subjects with body weights greater than or equal to 50 kg and a body mass index (BMI) between 18 kg/m2 and 32 kg/m2
• Female subjects of childbearing potential and males and their female partner(s) of childbearing potential must agree to use 2 forms of contraception, 1 of which must be a barrier method, during the study and for 30 days after the end of the study

You may not qualify if:

• Pregnant or lactating females or male partners of females who are pregnant or lactating.
• Subjects with any history of clinically significant bronchopulmonary, cardiovascular, cerebrovascular, hematologic, renal, hepatic, neurological, psychiatric, metabolic, or endocrine (eg, diabetes or thyroid disease) disease/disorder.
• Use of prescription or over-the-counter (OTC) drugs, including vitamins and herbal or dietary supplements within 2 weeks (4 weeks for enzyme inducers including St. John's Wort) or 5 half-lives (whichever is longer), prior to the baseline/check-in visit, unless in the opinion of the investigator, prior use of the medication will not interfere with the study procedures or compromise subject safety.
• Subjects with sustained supine or semi-supine systolic blood pressure of \< 90 or \> 140 mm Hg and supine or semi-supine diastolic blood pressure of \< 50 or \> 90 mm Hg at the screening or baseline/check-in visits.
• Subjects with a resting heart rate of \< 45 or \> 100 beats per minute at the screening or baseline/check in visits.
• Subjects with any clinically relevant deviation from normal during the physical examination, including vital signs at the screening or baseline/check-in visits.
• Subjects with a known history of hypercalcemia, hyperparathyroidism, or hypervitaminosis D.
• Use of calcium or vitamin D supplements (prescription or OTC) within 2 weeks prior to the baseline/check-in visit.
• Subjects with a history of allergic reactions or hypersensitivities to galacto-oligosaccharides or any significant drug-related or food-related allergy (such as anaphylaxis or hepatotoxicity).
• Regular use of probiotics, antacids, histamine type 2 (H2)-receptor blockers, proton pump inhibitors, or any medications that may alter the normal gastric environment and/or motility, or use of such medications within 2 weeks prior to the baseline/check-in visit.

Sponsors & Collaborators

• Ritter Pharmaceuticals, Inc.: lead

Study Sites (1)

Syneos Health

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Lactose Intolerance

Interventions

RP-G28

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Paul G Pearson, PhD

  Ritter Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: June 20, 2018
• Study Start: March 9, 2018
• Primary Completion: April 13, 2018
• Study Completion: April 13, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)