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

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05266248
• Other study ID #: PEP-2116
• Status: Completed
• Phase: Phase 1
• Start date: January 25, 2022
• Est. completion date: February 3, 2022

Study information

• Verified date: March 2022
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 3, 2022
• Est. primary completion date: February 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Other:
• 250 mg encapsulated caffeine
Zero calorie 500 ml (16.9 oz) flavored, carbonated energy beverage

Locations

Country	Name	City	State
United States	GCP Research	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration curve for plasma caffeine (AUC0-t)	Plasma caffeine pharmacokinetics	Changes from pre-dose to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, and 6 hours after the first sip of beverage ingestion
Primary	Peak caffeine concentration (Cmax)	Plasma caffeine pharmacokinetics	Changes from pre-dose to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, and 6 hours after the first sip of beverage ingestion
Primary	Time to maximal plasma caffeine concentration (Tmax)	Plasma caffeine pharmacokinetics	Changes from pre-dose to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, and 6 hours after the first sip of beverage ingestion
Primary	Plasma caffeine concentration by time profile	Plasma caffeine pharmacokinetics	Changes from pre-dose to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, and 6 hours after the first sip of beverage ingestion
Secondary	Vital sign measurement: Systolic and diastolic blood pressure	Safety parameter: Blood pressure	Changes in systolic and diastolic blood pressure over 6.5 hours, from prior to blood sample collection at -30 minutes pre-dose to 2 and 6 hours after the first sip of beverage ingestion
Secondary	Vital sign measurement: Heart rate	Safety parameter: Heart rate	Changes in heart rate over 6.5 hours, from prior to blood sample collection at -30 minutes pre-dose to 2 and 6 hours after the first sip of beverage ingestion
Secondary	Occurrence of Adverse events	Safety parameter: Treatment-emergent AEs (TEAEs) and adverse drug reactions (ADRs)	From the first sip of beverage ingestion (Time 0) of the first dosing day, until the subject exits the study the evening of the second and last dosing day. The two dosing days are approximately 7 days apart.