PharmacokineticsPhase 1NCT05266248
Pilot Study Characterizing the Pharmacokinetic Profile of a Novel Encapsulated Caffeine Beverage in the Fed and Fasted States
A Phase 1 study testing 250 mg encapsulated caffeine in people with Pharmacokinetics, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
Pilot study designed to characterize the plasma caffeine pharmacokinetic profile of encapsulated caffeine when consumed in the fasted and fed states. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- 250 mg encapsulated caffeine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2022to 3 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male and female volunteers aged 18 to 55 years.
- Have a BMI of 18 to 29.9 kg/m2 (inclusive)
- Are regular caffeine consumers (average 1 to 3 caffeine-containing beverages per day, not to exceed 400 mg/ per day)
- Willing to commit to 1 overnight stays (~36 hrs)
- Able to comprehend and willing to sign an Informed Consent Form (ICF)
- Willing to avoid caffeine-containing products for ≥48 hrs prior to dosing and until the completion of each test visit
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- Willing to avoid alcohol for ≥24 hrs prior to dosing
- Willing to fast 10 hrs prior to dosing
- Willing to stick to their usual dietary patterns and avoid grapefruit
- Willing to stick to their usual physical activity level throughout the study
- Willing to stick to their usual sleep pattern
- Willing and able to consume a high-fat, high-caloric breakfast
- 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.
Who cannot join
- 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
- Current or recent history (<30 days prior to Screening) of a clinically significant bacterial, fungal, or mycobacterial infection
- Current clinically significant viral infection
- 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
- Are pregnant or breastfeeding or planning to become pregnant
- Resting heart rate less than 45 bpm or greater than 100 bpm.
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- History of unstable ischemic heart disease or uncontrolled hypertension (blood pressure 150/90 mm Hg)
- History of significant surgery that may affect absorption of caffeine. Appendectomy and/or cholecystectomy will be allowed.
- Presence of a malabsorption syndrome possibly affecting drug/Product absorption (e.g., Crohn's disease or chronic pancreatitis).
- Extreme dietary habits, including but not limited to intentional consumption of a high fiber diet, gluten-free, low-carb, vegan, ketogenic.
- 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.
- 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
- 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.
- 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.
- 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.).
- Donation of blood in excess of 500 ml within 4 weeks prior to study entry or of plasma within 2 weeks prior to Screening.
- Receipt of blood products within 3 months prior to study entry.
- Subjects who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations
Trial locations and contacts
1 site in 1 country.
About this study
Pilot study designed to characterize the plasma caffeine pharmacokinetic profile of encapsulated caffeine when consumed in the fasted and fed states.
- Conditions
- Pharmacokinetics
- Being tested
- 250 mg encapsulated caffeine
- Keywords
- caffeine, plasma, encapsulated, beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
250 mg encapsulated caffeineOther
Zero calorie 500 ml (16.9 oz) flavored, carbonated energy beverage
| Study group | Role | What they receive |
|---|---|---|
| Fed state | Experimental | Standardized high fat breakfast before dosing Receives: Other: 250 mg encapsulated caffeine |
| Fasted state | Experimental | Remain fasted for 4 hours post-dose Receives: Other: 250 mg encapsulated caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration curve for plasma caffeine (AUC0-t)
Plasma caffeine pharmacokinetics
Measured: 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
Peak caffeine concentration (Cmax)
Plasma caffeine pharmacokinetics
Measured: 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
Time to maximal plasma caffeine concentration (Tmax)
Plasma caffeine pharmacokinetics
Measured: 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
Plasma caffeine concentration by time profile
Plasma caffeine pharmacokinetics
Measured: 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 outcomes (3)
Vital sign measurement: Systolic and diastolic blood pressure
Safety parameter: Blood pressure
Measured: 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
Vital sign measurement: Heart rate
Safety parameter: Heart rate
Measured: 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
Occurrence of Adverse events
Safety parameter: Treatment-emergent AEs (TEAEs) and adverse drug reactions (ADRs)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start25 Jan 2022
- Primary completion3 Feb 2022
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lawrence Galitz, MD, Principal investigator, GCP, Global Clinical Professionals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266248
- Sponsor's protocol ID
- PEP-2116
- Status last verified
- Mar 2022
- First submitted
- 26 Jan 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Characterizing the Pharmacokinetic Profile of a Novel Encapsulated Caffeine Beverage in the Fed and Fasted States
- ClinicalTrials.gov ID
- NCT05266248
- Acronym / sponsor ID
- PEP-2116
- Conditions
- Pharmacokinetics
- Keywords
- caffeine, plasma, encapsulated, beverage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot study designed to characterize the plasma caffeine pharmacokinetic profile of encapsulated caffeine when consumed in the fasted and fed states.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fed state | Experimental | Other: 250 mg encapsulated caffeineStandardized high fat breakfast before dosing |
| Fasted state | Experimental | Other: 250 mg encapsulated caffeineRemain fasted for 4 hours post-dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy adult male and female volunteers aged 18 to 55 years.
- Have a BMI of 18 to 29.9 kg/m2 (inclusive)
- Are regular caffeine consumers (average 1 to 3 caffeine-containing beverages per day, not to exceed 400 mg/ per day)
- Willing to commit to 1 overnight stays (~36 hrs)
- Able to comprehend and willing to sign an Informed Consent Form (ICF)
Key exclusion criteria (18 listed)
- 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
- Current or recent history (<30 days prior to Screening) of a clinically significant bacterial, fungal, or mycobacterial infection
- Current clinically significant viral infection
- 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
- Are pregnant or breastfeeding or planning to become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 250 mg encapsulated caffeineZero calorie 500 ml (16.9 oz) flavored, carbonated energy beverage | Other | Fasted state, Fed state |
Primary outcome
Area under the concentration curve for plasma caffeine (AUC0-t)
Time frame: 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
Plasma caffeine pharmacokinetics
Peak caffeine concentration (Cmax)
Time frame: 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
Plasma caffeine pharmacokinetics
Time to maximal plasma caffeine concentration (Tmax)
Time frame: 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
Plasma caffeine pharmacokinetics
Plasma caffeine concentration by time profile
Time frame: 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
Plasma caffeine pharmacokinetics
3 secondary outcomes
Vital sign measurement: Systolic and diastolic blood pressure
Time frame: 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
Vital sign measurement: Heart rate
Time frame: 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
Occurrence of Adverse events
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Galitz, MD principal investigator
GCP, Global Clinical Professionals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 250 mg encapsulated caffeine in people with Pharmacokinetics, run by PepsiCo Global R&D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration curve for plasma caffeine (AUC0-t) (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.