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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03563846
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Ritter Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Lactose Intolerance Drug: RP-G28 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 9, 2018
Actual Primary Completion Date : April 13, 2018
Actual Study Completion Date : April 13, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: galactic-oligosaccharide




Primary Outcome Measures :
  1. Area under the plasma concentration-time curve from time 0 extrapolated to infinity [ Time Frame: Days 2 and 1 pretreatment; Day 1 post-treatment, Day 1-3 washout, Day 3 and 4 post-treatment ]
    Assess systemic exposure of RP-G28 when administered in the fed and fasted state


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 2, 3, 2 and 1 days pretreatment; 1 - 13 days post-treatment ]
    Adverse events will be continuously monitored throughout the entire study, including follow-up.

  2. Serum chemistry [ Time Frame: 21 and 3 days pretreatment; day 4 post-treatment ]
    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.

  3. Hematology [ Time Frame: 21 and 3 days pretreatment; day 4 post-treatment ]
    Number of subjects with abnormal laboratory values will be flagged and summarized separately

  4. Urinalysis [ Time Frame: 2, 3, 2 and 1 days pretreatment; day 1 and 3 post-treatment ]
    Number of subjects with abnormal laboratory values will be flagged and summarized separately



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563846


Locations
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United States, Florida
Syneos Health
Miami, Florida, United States, 33136
Sponsors and Collaborators
Ritter Pharmaceuticals, Inc.
Investigators
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Study Director: Paul G Pearson, PhD Ritter Pharmaceuticals

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Responsible Party: Ritter Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03563846    
Other Study ID Numbers: G28-005
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lactose Intolerance
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases