Pilot Study Characterizing the Pharmacokinetic Profile of a Novel Encapsulated Caffeine Beverage in the Fed and Fasted States

NCT ID: NCT05266248

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-25
• Study Completion Date: 2022-02-03

Brief Summary

Pilot study designed to characterize the plasma caffeine pharmacokinetic profile of encapsulated caffeine when consumed in the fasted and fed states.

Conditions

Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Fed state

Standardized high fat breakfast before dosing

Group Type: EXPERIMENTAL

250 mg encapsulated caffeine

Intervention Type: OTHER

Zero calorie 500 ml (16.9 oz) flavored, carbonated energy beverage

Fasted state

Remain fasted for 4 hours post-dose

Group Type: EXPERIMENTAL

250 mg encapsulated caffeine

Intervention Type: OTHER

Zero calorie 500 ml (16.9 oz) flavored, carbonated energy beverage

Interventions

250 mg encapsulated caffeine

Zero calorie 500 ml (16.9 oz) flavored, carbonated energy beverage

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Healthy adult male and female volunteers aged 18 to 55 years.

2. Have a BMI of 18 to 29.9 kg/m2 (inclusive)

3. Are regular caffeine consumers (average 1 to 3 caffeine-containing beverages per day, not to exceed 400 mg/ per day)

4. Willing to commit to 1 overnight stays (~36 hrs)

5. Able to comprehend and willing to sign an Informed Consent Form (ICF)

6. Willing to avoid caffeine-containing products for ≥48 hrs prior to dosing and until the completion of each test visit

7. Willing to avoid alcohol for ≥24 hrs prior to dosing

8. Willing to fast 10 hrs prior to dosing

9. Willing to stick to their usual dietary patterns and avoid grapefruit

10. Willing to stick to their usual physical activity level throughout the study

11. Willing to stick to their usual sleep pattern

12. Willing and able to consume a high-fat, high-caloric breakfast

13. No participation in any clinical trial within the past 30 days or 5 half lives and throughout this study, or any PEP protocol within the past 6 months.

Exclusion Criteria

1. Reported history or clinical manifestations of significant metabolic (including type 1 or type 2 diabetes mellitus), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders unless deemed clinically not significant by investigator

2. Current or recent history (<30 days prior to Screening) of a clinically significant bacterial, fungal, or mycobacterial infection

3. Current clinically significant viral infection

4. History of malignancy within the past 5 years, with the exception of cured basal cell or squamous cell carcinoma of the skin within 6 months

5. Are pregnant or breastfeeding or planning to become pregnant

6. Resting heart rate less than 45 bpm or greater than 100 bpm.

7. History of unstable ischemic heart disease or uncontrolled hypertension (blood pressure 150/90 mm Hg)

8. History of significant surgery that may affect absorption of caffeine. Appendectomy and/or cholecystectomy will be allowed.

9. Presence of a malabsorption syndrome possibly affecting drug/Product absorption (e.g., Crohn's disease or chronic pancreatitis).

10. Extreme dietary habits, including but not limited to intentional consumption of a high fiber diet, gluten-free, low-carb, vegan, ketogenic.

11. History of alcoholism or drug addiction within 1 year prior to Screening, or current alcohol or drug use that, in the opinion of the investigator, will interfere with the subject's ability to comply with the dosing schedule and study evaluations.

12. More than one tobacco-containing or nicotine-containing product occasions per month on average, or use of such products within 48 hours prior to dosing of each study period

13. Use of any prescription or nonprescription drugs (including vitamins, minerals, and phytotherapeutic, herbal, or plant-derived preparations) is prohibited within 7 days prior to the dose of study product, unless deemed acceptable by the Investigator.

14. Use of any medication known to have an interaction with caffeine including oral contraceptives (e.g., medications metabolized via the CYP1A2 pathway). Contraceptives with localized effects (e.g., copper and hormonal IUDs, vaginal ring) are acceptable, methods with systemic effects (e.g., patch or subdermal implants/devices) are not.

15. Use of any medication known to alter the pH of the gastrointestinal tract (e.g., proton-pump inhibitors, histamine H2-receptor antagonists (H2 blockers), antacids, etc.).

16. Donation of blood in excess of 500 ml within 4 weeks prior to study entry or of plasma within 2 weeks prior to Screening.

17. Receipt of blood products within 3 months prior to study entry.

18. Subjects who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PepsiCo Global R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawrence Galitz, MD

Role: PRINCIPAL_INVESTIGATOR

GCP, Global Clinical Professionals

Locations

GCP Research

St. Petersburg, Florida, United States

Countries

United States

Other Identifiers

PEP-2116

Identifier Type: -

Identifier Source: org_study_id