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

Prospective, Open-Label, Randomized, Two-Period, Two-Sequence, Crossover Study Comparing RP-G28 Administered in the Fasted State and the Effect of a Standard Meal on the Pharmacokinetic Profile of RP-G28 in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Lactose Intolerance
• Intervention / Treatment: Drug: RP-G28

Detailed Description

This randomized, open-label, 2-period, 2-sequence, crossover study is designed to evaluate the effect of a standard meal on the pharmacokinetic (PK) profile of orally administered RP-G28, which is being developed for the treatment of lactose intolerance. The study consists of a screening visit (during the interval from Day -21 to Day -3), baseline/check-in to the clinical research unit (Day -2 to Day -1), 2 treatment periods (Day 1 and Day 3), a 48-hour washout between doses, check-out from the clinical research unit (Day 4), and 1 follow-up phone call conducted 7 to 10 days after the final dose of the study drug (i.e., during the interval from Day 10 to Day 13). The duration of subject study participation is approximately 5 weeks. Plasma samples for PK analysis will be taken at specified timepoints from 24 hours prior to each dose through 24 hours after each dose.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Syneos Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male and female subjects between 18 and 60 years of age
2. 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
3. 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

Exclusion Criteria:

1. Pregnant or lactating females or male partners of females who are pregnant or lactating.
2. 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.
3. 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.
4. 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.
5. Subjects with a resting heart rate of < 45 or > 100 beats per minute at the screening or baseline/check in visits.
6. Subjects with any clinically relevant deviation from normal during the physical examination, including vital signs at the screening or baseline/check-in visits.
7. Subjects with a known history of hypercalcemia, hyperparathyroidism, or hypervitaminosis D.
8. Use of calcium or vitamin D supplements (prescription or OTC) within 2 weeks prior to the baseline/check-in visit.
9. 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).
10. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RP-G28 administered in the fasted state; RP-G28, 15 g dissolved in water, administered in the fasted state	Drug: RP-G28; RP-G28 is a purified galacto-oligosaccharide (GOS) product; Other Names: galactic-oligosaccharide
EXPERIMENTAL: RP-G28 administered in the fed state; RP-G28, 15 g dissolved in water, administered immediately following the consumption of a standard non-dairy meal	Drug: RP-G28; RP-G28 is a purified galacto-oligosaccharide (GOS) product; Other Names: galactic-oligosaccharide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events will be continuously monitored throughout the entire study, including follow-up.	2, 3, 2 and 1 days pretreatment; 1 - 13 days post-treatment
Serum chemistry	Albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, calcium, chloride, carbon dioxide, creatinine, total bilirubin, gamma glutamyl transferase, glucose, lactic dehydrogenase (lactate dehydrogenase), phosphorus, potassium, sodium, total cholesterol, total protein, uric acid, and vitamin D.	21 and 3 days pretreatment; day 4 post-treatment
Hematology	Number of subjects with abnormal laboratory values will be flagged and summarized separately	21 and 3 days pretreatment; day 4 post-treatment
Urinalysis	Number of subjects with abnormal laboratory values will be flagged and summarized separately	2, 3, 2 and 1 days pretreatment; day 1 and 3 post-treatment

Collaborators and Investigators

• Sponsor: Ritter Pharmaceuticals, Inc.
• Investigators: Study Director: Paul G Pearson, PhD, Ritter Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 9, 2018
• Primary Completion (ACTUAL): April 13, 2018
• Study Completion (ACTUAL): April 13, 2018

Study Registration Dates

• First Submitted: April 2, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (ACTUAL): June 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Genetic Diseases, Inborn; Intestinal Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Malabsorption Syndromes; Lactose Intolerance
• Other Study ID Numbers: G28-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No