Metabolic SyndromePhase 1NCT05713773
Pharmacodynamics and Pharmacokinetics of 3 New Developed Coated Glucose Beads in 20 Obese Healthy Subjects
A Phase 1 study testing coated beads glucose (8 g) and caffeine anhydrous, coated beads glucose (8 g) and uncoated beads glucose (8 g) and caffeine anhydrous in people with Metabolic Syndrome and Obesity, run by Aphaia Pharma US LLC at 1 site in Romania.
Trial summary
This single-dose, randomized, open label, five-treatment, five-period, five-sequence crossover study was performed to assess pharmacodynamics (PD) and pharmacokinetics (PK) of three new developed coated Glucose beads formulations (containing glucose (8 g) and caffeine), one coated Glucose beads formulation (containing… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity
- What is being tested?
- coated beads glucose (8 g) and caffeine anhydrous, coated beads glucose (8 g) and uncoated beads glucose (8 g) and caffeine anhydrous
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteRomania
- Study dates
- 25 Oct 2019to 3 Dec 2019
- 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 obese, Caucasian male and female subjects 18 - 55 years of age
- Body mass index within the range of > 30.0 kg/m2
- Waist circumference: men > 102 cm; women > 88 cm
- Female subjects of childbearing potential agree to undergo pregnancy tests and to use an appropriate method of contraception (i.e., oral contraceptive steroids, intrauterine device, barrier method)
- Findings within the range of clinical acceptability in medical history (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study)
- Findings within the range of clinical acceptability in physical examination (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study)
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- Laboratory values within the normal range (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study)
- Normal ECG or abnormalities which the clinical investigator does not consider a disqualification for participation in the study
- Normal vital signs (normal blood pressure and heart rate measured under stabilized conditions at screening visit after at least 5 minutes of rest in sitting position) or abnormalities which the clinical investigator does not consider a disqualification for participation in the study
- Normal gastrointestinal (GI) function or abnormalities which the clinical investigator does not consider a disqualification for participation in the study
- Willingness to undergo screening and follow-up examinations (i.e., physical examinations and laboratory investigations before and after the treatment periods)
- Ability to comprehend subject information and willingness to sign the informed consent
- Non-smokers or mild to moderate smokers (less or equal 10 cigarettes daily)
Who cannot join
- Gastrointestinal, hepatic and renal diseases and/or pathological findings which might interfere with pharmacokinetics and pharmacodynamics of the investigational product
- Established diagnosis of type-1 or type-2 diabetes mellitus
- Treatment with insulin, insulin secretagogues (sulfonylurea derivatives, glinides, GLP-1 agonists (exenatide, lixisenatide, glutides), or thiazolidinediones (glitazones)
- Unexplained rise in blood glucose
- Treatment for constipation (including but not limited to lactulose or any other form of stool softeners, laxatives) or diarrhea (including but not limited to pectins. loperamide etc.) or any other medication known to interfere with gastrointestinal transit time, such as e.g., metoclopramide, opioids, or gastric Potential of Hydrogen (pH) (including but not limited to antacids, H2-receptor antagonists, prazole)
- Tea, coffee or other caffeine containing beverage drinkers (more than 0.4 L per day)
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- History of hypersensitivity to the investigational product or any related drugs or to any of the excipients
- History or presence of any clinically significant cardiovascular, pulmonary, hepatobiliary, renal, hematological, gastrointestinal, endocrinologic, immunologic, dermatologic. neurological, psychiatric, metabolic, musculoskeletal, or malignant disease, which the clinical investigator does not consider a disqualification for participation in the study
- Known heart failure (Grade I to IV of New York Heart Association classification)
- Significant renal disease. including nephritic syndrome chronic renal failure (defined as creatinine clearance< 60 mL/min and serum creatinine >180 μmol/L)
- Unexplained serum creatine phosphokinase (CPK) > 3-times the upper limit of normal (ULN) Subjects with a reason for CPK elevation may have the measurement repeated prior to randomization a CPK retest> 3-times ULN leads to exclusion
- Clinically significant illness or surgery within 4 weeks prior to dosing
- Less than 14 days after last acute disease
- Volunteers liable to orthostatic dysregulation, fainting, or blackouts
- Donation or loss of blood equal to or exceeding 500 ml during 90 days before the first administration of investigational product
- Participation in another study with an experimental drug within at least 3 months (or within five elimination half-lives of the previous experimental drug, whichever is longer) before the first administration of investigational product
- Any use of drug, prescribed or over-the-counter (OTC) (inclusive herbal remedies), within 2 weeks (or within six elimination half-lives of this medication, whichever is longer) prior to the first administration of investigational product except if this will not affect the outcome of the study in the opinion of the clinical investigator
- Unwillingness or inability to comply with the study protocol or study-related procedures (e.g., difficulty to stay fasting, consume the standard meals, or swallow the beads formulations; difficult venous access).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacodynamics and Pharmacokinetics of 3 New Developed Coated Glucose Beads Formulations After Single-dose Administration (Fasting Conditions) in 20 Obese Healthy Subjects
This single-dose, randomized, open label, five-treatment, five-period, five-sequence crossover study was performed to assess pharmacodynamics (PD) and pharmacokinetics (PK) of three new developed coated Glucose beads formulations (containing glucose (8 g) and caffeine), one coated Glucose beads formulation (containing glucose (8 g)) and one uncoated Glucose beads formulation (containing Glucose (8 g) and caffeine) after single-dose administration (fasting conditions) in 20 obese healthy subjects. After an overnight fasting of at least 10 hours the subjects were administered either glucose (8 g) or glucose (8 g) and caffeine starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position. At least 3 days wash-out period was kept between each treatment periods.
Read the detailed description
This single-dose, randomized, open label, five-treatment, five-period, five-sequence crossover study was performed to assess pharmacodynamics (PD) and pharmacokinetics (PK) of three new developed coated Glucose beads formulations (containing glucose (8 g) and caffeine), one coated Glucose beads formulation (containing glucose (8 g)) and one uncoated Glucose beads formulation (containing Glucose (8 g) and caffeine) after single-dose administration (fasting conditions) in 20 obese healthy subjects.
Only subjects who had given voluntarily their informed consent participated in the screening examination and, if found eligible as per study inclusion and exclusion criteria, were enrolled in the study. At least 13 hours before investigational product administration in each treatment period, subjects were admitted to the clinical site. During each treatment period the hospitalization period in the clinical unit was 13 hours before and up to 11 hours after investigational product administration.
Test products (T1, T 2, T3, T4, T5) was administered as single oral doses during the first, second, third, fourth and fifth treatment period corresponding to the randomization code under fasting conditions.
After an overnight fasting of at least 10 hours, the subjects were administered either glucose (8 g) or glucose (8 g) and caffeine starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position. According to the randomization code subjects were received on the respective study day one coated beads formulations (T1, T2, T3, T 4) or the uncoated beads formulation (T5).
A total of 17 blood samples were drawn for determination of Glucagon-like peptide-1 (GLP-1) levels and pharmacokinetic analysis of caffeine at the prescribed times, pre-dose (1.0 h, 0.5 hand 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration. Blood samples for glucose measurements was taken via an indwelling catheter or vein puncture from the forearm vein pre-dose (1.0 h, and 0 h) and at 0.5, 1.0, 2.0, 3.0, 4 0, 5.0, 6 0, 8.0 and 10.0 hours after investigational product administration.
Visual analogue scale (VAS) (appetite), VAS (stomach rumbles) were evaluated at the prescribed times pre-dose (0 h) and at 2, 4 and 10 hours after investigational product administration.
Wash-out periods of at least 3 days were separated the five treatment periods.
Within 7 days after last blood sampling in the last treatment period 12-lead electrocardiogram (ECG), vital signs, clinical routine laboratory parameters, physical examination and check of adverse events were repeated.
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- coated beads glucose (8 g) and caffeine anhydrous, coated beads glucose (8 g), uncoated beads glucose (8 g) and caffeine anhydrous
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coated beads glucose (8 g) and caffeine anhydrousDrug
Also called APH-001A
After an overnight fasting of about 10 hours the subjects were administered either glucose (8 g) or glucose (8 g) and caffeine starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position on Day 1.
coated beads glucose (8 g) and caffeine anhydrousDrug
Also called APH-001B
After an overnight fasting of about 10 hours the subjects were administered either glucose (8 g) or glucose (8 g) and caffeine starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position on Day 1.
coated beads glucose (8 g) and caffeine anhydrousDrug
Also called APH-001C
After an overnight fasting of about 10 hours the subjects were administered either glucose (8 g) or glucose (8 g) and caffeine starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position on Day 1.
coated beads glucose (8 g)Drug
Also called APH-001D
After an overnight fasting of about 10 hours the subjects were administered glucose (8 g) starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position on Day 1.
uncoated beads glucose (8 g) and caffeine anhydrousDrug
Also called APH-001E
After an overnight fasting of about 10 hours the subjects were administered either glucose (8 g) or glucose (8 g) and caffeine starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Test product 1 (T1) | Active comparator | Aphaia Pharma (APH)-001A: glucose coated beads containing 8 g glucose and caffeine anhydrous Receives: Drug: coated beads glucose (8 g) and caffeine anhydrous |
| Test product 2 (T2) | Active comparator | APH-001B: glucose coated beads containing 8 g glucose and caffeine anhydrous Receives: Drug: coated beads glucose (8 g) and caffeine anhydrous |
| Test product 3 (T3) | Active comparator | APH-001C: glucose coated beads containing 8 g glucose and caffeine anhydrous Receives: Drug: coated beads glucose (8 g) and caffeine anhydrous |
| Test product 4 (T4) | Active comparator | APH-001D: glucose coated beads containing 8 g glucose Receives: Drug: coated beads glucose (8 g) |
| Test product 5 (T5) | Active comparator | APH-001E: uncoated beads containing 8 g glucose and caffeine anhydrous Receives: Drug: uncoated beads glucose (8 g) and caffeine anhydrous |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-1
Area under the plasma concentration-time curve (AUC(0-t))
Measured: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
GLP-1
AUC(1.5h-6h)
Measured: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
GLP-1
Adjusted area under the plasma concentration-time cur (AUCadj(1.5h-6h))
Measured: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
GLP-1
Maximum plasma concentration (Cmax(0-t))
Measured: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
GLP-1
Cmax(1.5h-6h)
Measured: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
GLP-1
Cmax,adj(1.5h-6h)
Measured: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
GLP-1
time to reach maximum plasma concentration (tmax(0-t))
Measured: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
GLP-1
tmax(1.5h-6h)
Measured: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
GLP-1
Duration of time during the concentration in the plasma concentration-time curve exceeds at least 50 % of Cmax(1.5h-6h)
Measured: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
Secondary outcomes (14)
Pharmacokinetics of Caffeine
AUC(0-t)
Measured: Pre-dose (1.0 h, 0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
Pharmacokinetics of Caffeine
Cmax(0-t)
Measured: Pre-dose (1.0 h, 0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
Pharmacokinetics of Caffeine
tmax(0-t)
Measured: Pre-dose (1.0 h, 0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
Pharmacokinetics of Caffeine
tlag
Measured: Pre-dose (1.0 h, 0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
Pharmacokinetics of Glucose
AUC(0-t)
Measured: Venous blood glucose measurement at the prescribed times pre-dose (-1.0 h, 0 h) and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0 and 10.0 hours after investigational product administration
Pharmacokinetics of Glucose
Cmax(0-t)
Measured: Venous blood glucose measurement at the prescribed times pre-dose (-1.0 h, 0 h) and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0 and 10.0 hours after investigational product administration
Pharmacokinetics of Glucose
tmax(0-t)
Measured: Venous blood glucose measurement at the prescribed times pre-dose (-1.0 h, 0 h) and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0 and 10.0 hours after investigational product administration
Visual analogue scale (VAS) appetite
VAS for appetite with score of 1 - 10 was measured
Measured: VAS (appetite) at the prescribed times pre-dose (0 h) and 2, 4 and 10 hours after investigational product administration.
VAS stomach rumbles
VAS for stomach rumbles with score of 1 - 10 was measured
Measured: VAS (stomach rumbles) at the prescribed times pre-dose (0 h) and 2, 4 and 10 hours after investigational product administration.
Tolerability and safety
12-lead ECG
Measured: Within 7 days after last blood sampling in the last treatment period
Tolerability and safety
vital signs
Measured: Within 7 days after last blood sampling in the last treatment period
Tolerability and safety
clinical routine laboratory parameters
Measured: Within 7 days after last blood sampling in the last treatment period
Tolerability and safety
physical examination
Measured: Within 7 days after last blood sampling in the last treatment period
Tolerability and safety
check of adverse events
Measured: Within 7 days after last blood sampling in the last treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start25 Oct 2019
- Primary completion3 Dec 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- single-dose, randomized, open label, five-treatment, five-period, five-sequence crossover, at one study site
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aphaia Pharma US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ACC GmbH Analytical Clinical Concepts, Germany, Nova-Clin Medical Research Center S.R.L., Romania, BioClinica, Inc., Galephar Pharmaceutical Research (PR), Inc, Puerto Rico
- Responsible party
- Sponsor
- Investigators
- Carmen Vizman, Doctor, Principal investigator, Aphaia Pharma AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713773
- Sponsor's protocol ID
- 017B19
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamics and Pharmacokinetics of 3 New Developed Coated Glucose Beads Formulations After Single-dose Administration (Fasting Conditions) in 20 Obese Healthy Subjects
- ClinicalTrials.gov ID
- NCT05713773
- Acronym / sponsor ID
- 017B19
- Conditions
- Metabolic Syndrome, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aphaia Pharma US LLCIndustry (pharma, biotech, devices)
- Collaborators
- ACC GmbH Analytical Clinical Concepts, Germany, Nova-Clin Medical Research Center S.R.L., Romania, BioClinica, Inc., Galephar Pharmaceutical Research (PR), Inc, Puerto Rico
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 6 Feb 2023 (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.
This single-dose, randomized, open label, five-treatment, five-period, five-sequence crossover study was performed to assess pharmacodynamics (PD) and pharmacokinetics (PK) of three new developed coated Glucose beads formulations (containing glucose (8 g) and caffeine), one coated Glucose beads formulation (containing glucose (8 g)) and one uncoated Glucose beads formulation (containing Glucose (8 g) and caffeine) after single-dose administration (fasting conditions) in 20 obese healthy subjects. After an overnight fasting of at least 10 hours the subjects were administered either glucose (8 g) or glucose (8 g) and caffeine starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position. At least 3 days wash-out period was kept between each treatment periods.
Detailed description
This single-dose, randomized, open label, five-treatment, five-period, five-sequence crossover study was performed to assess pharmacodynamics (PD) and pharmacokinetics (PK) of three new developed coated Glucose beads formulations (containing glucose (8 g) and caffeine), one coated Glucose beads formulation (containing glucose (8 g)) and one uncoated Glucose beads formulation (containing Glucose (8 g) and caffeine) after single-dose administration (fasting conditions) in 20 obese healthy subjects.
Only subjects who had given voluntarily their informed consent participated in the screening examination and, if found eligible as per study inclusion and exclusion criteria, were enrolled in the study. At least 13 hours before investigational product administration in each treatment period, subjects were admitted to the clinical site. During each treatment period the hospitalization period in the clinical unit was 13 hours before and up to 11 hours after investigational product administration.
Test products (T1, T 2, T3, T4, T5) was administered as single oral doses during the first, second, third, fourth and fifth treatment period corresponding to the randomization code under fasting conditions.
After an overnight fasting of at least 10 hours, the subjects were administered either glucose (8 g) or glucose (8 g) and caffeine starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position. According to the randomization code subjects were received on the respective study day one coated beads formulations (T1, T2, T3, T 4) or the uncoated beads formulation (T5).
A total of 17 blood samples were drawn for determination of Glucagon-like peptide-1 (GLP-1) levels and pharmacokinetic analysis of caffeine at the prescribed times, pre-dose (1.0 h, 0.5 hand 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration. Blood samples for glucose measurements was taken via an indwelling catheter or vein puncture from the forearm vein pre-dose (1.0 h, and 0 h) and at 0.5, 1.0, 2.0, 3.0, 4 0, 5.0, 6 0, 8.0 and 10.0 hours after investigational product administration.
Visual analogue scale (VAS) (appetite), VAS (stomach rumbles) were evaluated at the prescribed times pre-dose (0 h) and at 2, 4 and 10 hours after investigational product administration.
Wash-out periods of at least 3 days were separated the five treatment periods.
Within 7 days after last blood sampling in the last treatment period 12-lead electrocardiogram (ECG), vital signs, clinical routine laboratory parameters, physical examination and check of adverse events were repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- single-dose, randomized, open label, five-treatment, five-period, five-sequence crossover, at one study site
| Arm | Type | Receives |
|---|---|---|
| Test product 1 (T1) | Active comparator | Drug: coated beads glucose (8 g) and caffeine anhydrousAphaia Pharma (APH)-001A: glucose coated beads containing 8 g glucose and caffeine anhydrous |
| Test product 2 (T2) | Active comparator | Drug: coated beads glucose (8 g) and caffeine anhydrousAPH-001B: glucose coated beads containing 8 g glucose and caffeine anhydrous |
| Test product 3 (T3) | Active comparator | Drug: coated beads glucose (8 g) and caffeine anhydrousAPH-001C: glucose coated beads containing 8 g glucose and caffeine anhydrous |
| Test product 4 (T4) | Active comparator | Drug: coated beads glucose (8 g)APH-001D: glucose coated beads containing 8 g glucose |
| Test product 5 (T5) | Active comparator | Drug: uncoated beads glucose (8 g) and caffeine anhydrousAPH-001E: uncoated beads containing 8 g glucose and caffeine anhydrous |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy obese, Caucasian male and female subjects 18 - 55 years of age
- Body mass index within the range of > 30.0 kg/m2
- Waist circumference: men > 102 cm; women > 88 cm
- Female subjects of childbearing potential agree to undergo pregnancy tests and to use an appropriate method of contraception (i.e., oral contraceptive steroids, intrauterine device, barrier method)
- Findings within the range of clinical acceptability in medical history (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study)
Key exclusion criteria (18 listed)
- Gastrointestinal, hepatic and renal diseases and/or pathological findings which might interfere with pharmacokinetics and pharmacodynamics of the investigational product
- Established diagnosis of type-1 or type-2 diabetes mellitus
- Treatment with insulin, insulin secretagogues (sulfonylurea derivatives, glinides, GLP-1 agonists (exenatide, lixisenatide, glutides), or thiazolidinediones (glitazones)
- Unexplained rise in blood glucose
- Treatment for constipation (including but not limited to lactulose or any other form of stool softeners, laxatives) or diarrhea (including but not limited to pectins. loperamide etc.) or any other medication known to interfere with gastrointestinal transit time, such as e.g., metoclopramide, opioids, or gastric Potential of Hydrogen (pH) (including but not limited to antacids, H2-receptor antagonists, prazole)
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 |
|---|---|---|
| coated beads glucose (8 g) and caffeine anhydrousAlso: APH-001AAfter an overnight fasting of about 10 hours the subjects were administered either glucose (8 g) or glucose (8 g) and caffeine starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position on Day 1. | Drug | Test product 1 (T1) |
| coated beads glucose (8 g) and caffeine anhydrousAlso: APH-001BAfter an overnight fasting of about 10 hours the subjects were administered either glucose (8 g) or glucose (8 g) and caffeine starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position on Day 1. | Drug | Test product 2 (T2) |
| coated beads glucose (8 g) and caffeine anhydrousAlso: APH-001CAfter an overnight fasting of about 10 hours the subjects were administered either glucose (8 g) or glucose (8 g) and caffeine starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position on Day 1. | Drug | Test product 3 (T3) |
| coated beads glucose (8 g)Also: APH-001DAfter an overnight fasting of about 10 hours the subjects were administered glucose (8 g) starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position on Day 1. | Drug | Test product 4 (T4) |
| uncoated beads glucose (8 g) and caffeine anhydrousAlso: APH-001EAfter an overnight fasting of about 10 hours the subjects were administered either glucose (8 g) or glucose (8 g) and caffeine starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position on Day 1. | Drug | Test product 5 (T5) |
Primary outcome
GLP-1
Time frame: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
Area under the plasma concentration-time curve (AUC(0-t))
GLP-1
Time frame: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
AUC(1.5h-6h)
GLP-1
Time frame: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
Adjusted area under the plasma concentration-time cur (AUCadj(1.5h-6h))
GLP-1
Time frame: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
Maximum plasma concentration (Cmax(0-t))
GLP-1
Time frame: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
Cmax(1.5h-6h)
GLP-1
Time frame: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
Cmax,adj(1.5h-6h)
GLP-1
Time frame: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
time to reach maximum plasma concentration (tmax(0-t))
GLP-1
Time frame: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
tmax(1.5h-6h)
GLP-1
Time frame: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
Duration of time during the concentration in the plasma concentration-time curve exceeds at least 50 % of Cmax(1.5h-6h)
14 secondary outcomes
Pharmacokinetics of Caffeine
Time frame: Pre-dose (1.0 h, 0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
Pharmacokinetics of Caffeine
Time frame: Pre-dose (1.0 h, 0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
Pharmacokinetics of Caffeine
Time frame: Pre-dose (1.0 h, 0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
Pharmacokinetics of Caffeine
Time frame: Pre-dose (1.0 h, 0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration
Pharmacokinetics of Glucose
Time frame: Venous blood glucose measurement at the prescribed times pre-dose (-1.0 h, 0 h) and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0 and 10.0 hours after investigational product administration
Pharmacokinetics of Glucose
Time frame: Venous blood glucose measurement at the prescribed times pre-dose (-1.0 h, 0 h) and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0 and 10.0 hours after investigational product administration
Pharmacokinetics of Glucose
Time frame: Venous blood glucose measurement at the prescribed times pre-dose (-1.0 h, 0 h) and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0 and 10.0 hours after investigational product administration
Visual analogue scale (VAS) appetite
Time frame: VAS (appetite) at the prescribed times pre-dose (0 h) and 2, 4 and 10 hours after investigational product administration.
VAS stomach rumbles
Time frame: VAS (stomach rumbles) at the prescribed times pre-dose (0 h) and 2, 4 and 10 hours after investigational product administration.
Tolerability and safety
Time frame: Within 7 days after last blood sampling in the last treatment period
Tolerability and safety
Time frame: Within 7 days after last blood sampling in the last treatment period
Tolerability and safety
Time frame: Within 7 days after last blood sampling in the last treatment period
Tolerability and safety
Time frame: Within 7 days after last blood sampling in the last treatment period
Tolerability and safety
Time frame: Within 7 days after last blood sampling in the last treatment period
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 6 Feb 2023.
- 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.
Carmen Vizman, Doctor principal investigator
Aphaia Pharma AG
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 coated beads glucose (8 g) and caffeine anhydrous, coated beads glucose (8 g) and uncoated beads glucose (8 g) and caffeine anhydrous in people with Metabolic Syndrome and Obesity, run by Aphaia Pharma US LLC at 1 site in Romania.
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 6 Feb 2023. 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 Romania. 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?
GLP-1 (time frame: Pre-dose (-1.0 h, -0.5 h and 0 h) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0 and 10.0 hours after investigational product administration). The study lists 9 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 6 Feb 2023.