ObesePhase 1NCT05737927
Pharmacodynamics and Pharmacokinetics of Different Glucose Bead Formulations in Obese Healthy Subjects
A Phase 1 study testing Glucose 8 g coated beads (47% w/w), Glucose 12 g coated beads (47% w/w) and Glucose 16 g coated beads (47% w/w) in people with Obese, run by Aphaia Pharma US LLC at 1 site in Romania.
Trial summary
The goal of this clinical study was to assess pharmacodynamics (PD) and pharmacokinetics (PK) of different Glucose beads formulations in obese healthy subjects under fasting condition. The study was designed in 2 parts. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese
- What is being tested?
- Glucose 8 g coated beads (47% w/w), Glucose 12 g coated beads (47% w/w) and Glucose 16 g coated beads (47% w/w)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteRomania
- Study dates
- 16 Sep 2020to 9 Nov 2020
- 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)
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- 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)
- 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 stabilised 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 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
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, prazoles)
- History of hypersensitivity to the investigational product or any related drugs or to any of the excipients
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- 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 abnormal laboratory values
- Clinically significant ECG findings
- Clinically significant vital signs
- 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
- History of, or current compulsive alcohol abuse (more than a total of 10 drinks weekly whereby one drink corresponds to 500 ml beer, 200 ml wine or 50 g spirits); or regular exposure to other substances of abuse
- Donation or loss of blood equal to or exceeding 500 ml during 90 days before the first administration of investigational product
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis C-virus (HCV)
- 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
- Pregnant women (positive pregnancy test)
- Lactating women
- Failure to provide informed consent
- 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)
- Positive result of rRT-PCR test to detect infection with the new SARS-CoV-2 coronavirus
Trial locations and contacts
1 site in 1 country.
Romania1 site
NovaClin Medical Research Center S.R.L
Timișoara, Romania, 300696
About this study
Official title: Pharmacodynamics and Pharmacokinetics of Different Coated and Uncoated Formulations of Glucose Beads After Single and Multiple Dose Administration Under Fasting Conditions in Obese Healthy Subjects
The goal of this clinical study was to assess pharmacodynamics (PD) and pharmacokinetics (PK) of different Glucose beads formulations in obese healthy subjects under fasting condition. The study was designed in 2 parts.
Part 1 (single-dose) of the study was randomized, open label, five-treatment, five-period, five-sequence, crossover and single-centric. Treatment arms were three dosages of a coated Glucose beads formulation (47% w/w glucose/bead; 8 g [T1], 12 g [T2] and 16 g glucose [T3]), one uncoated Glucose beads formulation (47% w/w glucose/bead; 12 g glucose [T4]) and one coated Glucose beads formulation (60% w/w glucose/bead;12 g glucose [T5]).
Part 2 (multiple-dose) of the study was open label, one-treatment, one-period and single-centric. Treatment arm was coated Glucose beads formulation (12 g glucose [T2]).
Read the detailed description
Twenty healthy obese subjects were planned for this study. Eligible subjects fulfilling the inclusion/ exclusion criteria and who had willing to give their informed consent were enrolled for screening examination and, if found eligible, enrolled in the study.
Before each hospitalization, on day -1, subjects with Real-Time Reverse Transcription-Polymerase Chain Reaction (rRT-PCR) tested negative for the new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) coronavirus were hospitalized. At the hospitalization examination physical examinations (weight), vital signs, pregnancy test for female subjects, alcohol breath test, as well as a check of adverse events, inclusion and exclusion criteria and restrictions were performed. Subjects were admitted to the clinical site at least 13 hours prior to the administration of investigational product in each treatment period.
During each treatment period the hospitalization period in the clinical unit was 13 hours before and up to 11 hours after investigational product administration. Part 1: Single dose After an overnight fasting of at least 10 hours the subjects was administered either 8 g glucose (T1), 12 g glucose (T2), 16 g glucose (T3) of the coated Glucose beads formulation (47%), the uncoated Glucose beads formulation (T4) containing 12 g glucose (47%) or the coated Glucose beads formulation (60% w/w glucose/bead; 12 g glucose [T5]) starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position.
17 blood samples was drawn for determination of glucagon-like polypeptide 1 (GLP-1) levels at the prescribed times pre-dose (-1.0 h, -0.5 and 0.0 h [within 5 minutes]) 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.
A fraction of one pre-dose sample (-1.0 h) before investigational product administration in treatment period I was also used to determine circulating concentration of microRNA (miRNA) 1983.
One additional blood sample was drawn pre-dose (-1.0 h) before investigational product administration in treatment period I for determination of adiponectin level.
Fractions of the blood samples was also used to determine circulating concentrations of 13 diabetes and obesity related hormones and inflammatory proteins (amylin c-peptide, ghrelin, gastric inhibitory polypeptide [GIP], GLP-1, glucagon, interleukin-6 [IL-6], insulin, leptin, monocyte chemoattractant protein-1 [MCP-1], pancreatic polypeptide [PP], peptide tyrosine tyrosine [PYY], tumor necrosis factor alpha [TNFa]) with formulation T3 (16 g glucose).
Part 2: Multiple dose After an overnight fasting of at least 10 hours, the subjects were administered the new developed Glucose beads formulation containing 12 g glucose starting at 8:00 (time 0: administration time was be staggered beginning at 8.00 for the first group of subjects) in sitting position for the 3 days.
Standard meals were provided 0.5 h (morning meal), 4.5 h (mid-day meal) and 10 h (evening meal) after investigational product administration.
Blood samples were drawn for determination of GLP-1 levels before (-1.0 h, -0.5 h and 0 h [within 5 minutes]) each investigational product administration (total 9 samples) on each day.
Venous blood glucose measurement was performed before each investigational product administration (total 3 samples).
On Day 4, after an overnight fasting of at least 10 hours the subjects were administered the Glucose beads formulation containing 12 g glucose starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position.
17 blood samples were drawn for determination of GLP-1 levels at the prescribed times pre-dose (-1.0 h, -0.5 h and 0 h [within 5 minutes]) 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.
A fraction of one blood sample (10.0 h) was also used to determine circulating concentrations of miRNA1983.
One additional blood sample was drawn (10.0 h) for determination of adiponectin level.
Fractions of the blood samples was also used to determine circulating concentrations of 13 diabetes and obesity related hormones and inflammatory proteins (amylin c-peptide, ghrelin, GIP, GLP-1, glucagon, IL-6, insulin, leptin, MCP-1, PP, PYY, TNFa).
Follow-up Within 7 days after last blood sampling in the last treatment period, 12-lead ECG, clinical routine laboratory parameters, vital signs (blood pressure, heart rate, body temperature) and physical examination were repeated. Furthermore questioning for subjective well-being and questioning of adverse events was performed.
Wash-out periods Wash-out periods of at least 3 days separated the five treatment periods. A wash-out period of at least 3 days separated part 1 (single dose) and part 2 (multiple dose) of the study.
- Conditions
- Obese
- Being tested
- Glucose 8 g coated beads (47% w/w), Glucose 12 g coated beads (47% w/w), Glucose 16 g coated beads (47% w/w), Glucose 12 g uncoated beads, Glucose 12 g coated beads (60% w/w)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose 8 g coated beads (47% w/w)Drug
Also called APHD-008
After an overnight fasting of about 10 hours, the subjects were administered 8 g glucose of the coated Glucose beads formulation starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position.
Glucose 12 g coated beads (47% w/w)Drug
Also called APHD-012
After an overnight fasting of about 10 hours, the subjects were administered 12 g glucose of the coated Glucose beads formulation starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position.
Glucose 16 g coated beads (47% w/w)Drug
Also called APHD-016
After an overnight fasting of about 10 hours, the subjects were administered 16 g glucose of the coated Glucose beads formulation starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position.
Glucose 12 g uncoated beadsDrug
Also called APHD-012P
After an overnight fasting of about 10 hours, the subjects were administered the uncoated Glucose beads formulation containing 12 g glucose starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position.
Glucose 12 g coated beads (60% w/w)Drug
Also called APHD-012-60
After an overnight fasting of about 10 hours, the subjects were administered the coated Glucose beads formulation (60 % w/w glucose/bead; 12 g glucose) starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position.
Glucose 12 g coated beads (47% w/w)Drug
Also called APHD-012
After an overnight fasting of at least 10 hours, the subjects were administered the new developed Glucose beads formulation containing 12 g glucose starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position. Treatment duration: Day 1 - Day 4
| Study group | Role | What they receive |
|---|---|---|
| SINGLE DOSE- TEST PRODUCT 1 (T1) | Active comparator | Oral coated beads 8 g glucose (content glucose/bead 47% w/w) Receives: Drug: Glucose 8 g coated beads (47% w/w) |
| SINGLE DOSE- TEST PRODUCT 2 (T2) | Active comparator | Oral coated beads 12 g glucose (content glucose/bead 47% w/w) Receives: Drug: Glucose 12 g coated beads (47% w/w) |
| SINGLE DOSE- TEST PRODUCT 3 (T3) | Active comparator | Oral coated beads 16 g glucose (content glucose/bead 47% w/w) Receives: Drug: Glucose 16 g coated beads (47% w/w) |
| SINGLE DOSE- TEST PRODUCT 4 (T4) | Active comparator | Oral uncoated beads 12 g glucose Receives: Drug: Glucose 12 g uncoated beads |
| SINGLE DOSE- TEST PRODUCT 5 (T5) | Active comparator | Oral coated beads 12 g glucose (content glucose/bead 60% w/w) Receives: Drug: Glucose 12 g coated beads (60% w/w) |
| MULTIPLE DOSE- TEST PRODUCT 2 (T2) | Active comparator | Oral coated beads 12 g glucose (content glucose/bead 47% w/w) Receives: Drug: Glucose 12 g coated beads (47% w/w) |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-1
Part 1: Area under the plasma concentration-time curve from the first time point zero to the last measured concentration (AUC[0-t])
Measured: Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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
Part 1: Area under the plasma concentration-time curve from the time point 1.5 hours to 8 hours (AUC[1.5 hours-8 hours])
Measured: Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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
Part 1: Adjusted area under the plasma concentration-time curve from the time point 1.5 hours to 8 hours (AUCadj.[1.5 hours-8 hours])
Measured: Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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
Part 1: Maximum plasma concentration (Cmax[0-t])
Measured: Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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
Part 1: Maximum plasma concentration between the time point 1.5 hours to 8 hours (Cmax[1.5 hours-8 hours])
Measured: Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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
Part 1: Adjusted maximum plasma concentration between the time point 1.5 hours to 8 hours (Cmax,adj.[1.5 hours-8 hours])
Measured: Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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
Part 1: Time of maximum plasma concentration (tmax[0-t])
Measured: Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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
Part 1: Time of maximum plasma concentration between the time point 1.5 hours to 8 hours (tmax[1.5 hours-8 hours])
Measured: Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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
Part 2: Area under the plasma concentration-time curve during a dosage interval at steady state (AUC[0-τ])
Measured: Day 1-3:- pre-dose (-1.0 hour, -0.5 hour and 0 hour). Day 4:- Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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
Part 2: Maximum plasma concentration at steady state (Cmax,ss)
Measured: Day 1-3:- pre-dose (-1.0 hour, -0.5 hour and 0 hour). Day 4:- Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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
Part 2: Concentration at the end of the dosing interval at steady state (Cτ,ss)
Measured: Day 1-3:- pre-dose (-1.0 hour, -0.5 hour and 0 hour). Day 4:- Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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 (6)
Glucose levels
Part 1: AUC(0-t)
Measured: Pre-dose (-1.0 hour, 0 hour [within 5 minutes]) 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.
Glucose levels
Part 1: Cmax
Measured: Pre-dose (-1.0 hour, 0 hour [within 5 minutes]) 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.
Glucose levels
Part 2: Minimum blood concentration at steady state (Cmin,ss)
Measured: Day 1- Day 3:- Pre-dose (3 samples). Day 4:- Pre-dose (-1.0 hour, 0 hour [within 5 minutes]) 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.
Glucose levels
Part 2: Time of maximum blood concentration at steady state (tmax,ss)
Measured: Day 1- Day 3:- Pre-dose (3 samples). Day 4:- Pre-dose (-1.0 hour, 0 hour [within 5 minutes]) 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 appetite
Visual analogue scale for appetite ranges from 0 - 10. 0 represents very weak appetite while 10 represent very strong appetite.
Measured: Pre-dose (0 hour) and 2, 3, 4, 5, 6, 8 and 10 hours after investigational product administration.
Visual analogue scale stomach rumbles
Visual analogue scale for stomach rumbles ranges from 0 - 10. 0 represents not hungry at all while 10 represent as hungry as I have ever felt.
Measured: Pre-dose (0 hour) and 2, 3, 4, 5, 6, 8 and 10 hours after investigational product administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start16 Sep 2020
- Primary completion9 Nov 2020
- Study completion9 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies 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
- Part 1: randomised, open label, five-treatment, five-period, five-sequence, crossover, at one study site Part 2: open label, one-treatment, one-period, 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
- NovaClin Medical Research Center S.R.L, ACC GmbH Analytical Clinical Concepts, SC Bioclinica SA, Galephar Pharmaceutical Research (PR), Inc.
- Responsible party
- Sponsor
- Investigators
- Carmen Vizman, Principal investigator, NovaClin Medical Research Center S.R.L
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737927
- Sponsor's protocol ID
- 008B20
- Status last verified
- Sep 2025
- First submitted
- 19 Jan 2023
- Last updated
- 18 Sep 2025
- 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 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamics and Pharmacokinetics of Different Coated and Uncoated Formulations of Glucose Beads After Single and Multiple Dose Administration Under Fasting Conditions in Obese Healthy Subjects
- ClinicalTrials.gov ID
- NCT05737927
- Acronym / sponsor ID
- 008B20
- Conditions
- Obese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aphaia Pharma US LLCIndustry (pharma, biotech, devices)
- Collaborators
- NovaClin Medical Research Center S.R.L, ACC GmbH Analytical Clinical Concepts, SC Bioclinica SA, Galephar Pharmaceutical Research (PR), Inc.
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 21 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.
The goal of this clinical study was to assess pharmacodynamics (PD) and pharmacokinetics (PK) of different Glucose beads formulations in obese healthy subjects under fasting condition. The study was designed in 2 parts.
Part 1 (single-dose) of the study was randomized, open label, five-treatment, five-period, five-sequence, crossover and single-centric. Treatment arms were three dosages of a coated Glucose beads formulation (47% w/w glucose/bead; 8 g [T1], 12 g [T2] and 16 g glucose [T3]), one uncoated Glucose beads formulation (47% w/w glucose/bead; 12 g glucose [T4]) and one coated Glucose beads formulation (60% w/w glucose/bead;12 g glucose [T5]).
Part 2 (multiple-dose) of the study was open label, one-treatment, one-period and single-centric. Treatment arm was coated Glucose beads formulation (12 g glucose [T2]).
Detailed description
Twenty healthy obese subjects were planned for this study. Eligible subjects fulfilling the inclusion/ exclusion criteria and who had willing to give their informed consent were enrolled for screening examination and, if found eligible, enrolled in the study.
Before each hospitalization, on day -1, subjects with Real-Time Reverse Transcription-Polymerase Chain Reaction (rRT-PCR) tested negative for the new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) coronavirus were hospitalized. At the hospitalization examination physical examinations (weight), vital signs, pregnancy test for female subjects, alcohol breath test, as well as a check of adverse events, inclusion and exclusion criteria and restrictions were performed. Subjects were admitted to the clinical site at least 13 hours prior to the administration of investigational product in each treatment period.
During each treatment period the hospitalization period in the clinical unit was 13 hours before and up to 11 hours after investigational product administration. Part 1: Single dose After an overnight fasting of at least 10 hours the subjects was administered either 8 g glucose (T1), 12 g glucose (T2), 16 g glucose (T3) of the coated Glucose beads formulation (47%), the uncoated Glucose beads formulation (T4) containing 12 g glucose (47%) or the coated Glucose beads formulation (60% w/w glucose/bead; 12 g glucose [T5]) starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position.
17 blood samples was drawn for determination of glucagon-like polypeptide 1 (GLP-1) levels at the prescribed times pre-dose (-1.0 h, -0.5 and 0.0 h [within 5 minutes]) 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.
A fraction of one pre-dose sample (-1.0 h) before investigational product administration in treatment period I was also used to determine circulating concentration of microRNA (miRNA) 1983.
One additional blood sample was drawn pre-dose (-1.0 h) before investigational product administration in treatment period I for determination of adiponectin level.
Fractions of the blood samples was also used to determine circulating concentrations of 13 diabetes and obesity related hormones and inflammatory proteins (amylin c-peptide, ghrelin, gastric inhibitory polypeptide [GIP], GLP-1, glucagon, interleukin-6 [IL-6], insulin, leptin, monocyte chemoattractant protein-1 [MCP-1], pancreatic polypeptide [PP], peptide tyrosine tyrosine [PYY], tumor necrosis factor alpha [TNFa]) with formulation T3 (16 g glucose).
Part 2: Multiple dose After an overnight fasting of at least 10 hours, the subjects were administered the new developed Glucose beads formulation containing 12 g glucose starting at 8:00 (time 0: administration time was be staggered beginning at 8.00 for the first group of subjects) in sitting position for the 3 days.
Standard meals were provided 0.5 h (morning meal), 4.5 h (mid-day meal) and 10 h (evening meal) after investigational product administration.
Blood samples were drawn for determination of GLP-1 levels before (-1.0 h, -0.5 h and 0 h [within 5 minutes]) each investigational product administration (total 9 samples) on each day.
Venous blood glucose measurement was performed before each investigational product administration (total 3 samples).
On Day 4, after an overnight fasting of at least 10 hours the subjects were administered the Glucose beads formulation containing 12 g glucose starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position.
17 blood samples were drawn for determination of GLP-1 levels at the prescribed times pre-dose (-1.0 h, -0.5 h and 0 h [within 5 minutes]) 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.
A fraction of one blood sample (10.0 h) was also used to determine circulating concentrations of miRNA1983.
One additional blood sample was drawn (10.0 h) for determination of adiponectin level.
Fractions of the blood samples was also used to determine circulating concentrations of 13 diabetes and obesity related hormones and inflammatory proteins (amylin c-peptide, ghrelin, GIP, GLP-1, glucagon, IL-6, insulin, leptin, MCP-1, PP, PYY, TNFa).
Follow-up Within 7 days after last blood sampling in the last treatment period, 12-lead ECG, clinical routine laboratory parameters, vital signs (blood pressure, heart rate, body temperature) and physical examination were repeated. Furthermore questioning for subjective well-being and questioning of adverse events was performed.
Wash-out periods Wash-out periods of at least 3 days separated the five treatment periods. A wash-out period of at least 3 days separated part 1 (single dose) and part 2 (multiple dose) of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Part 1: randomised, open label, five-treatment, five-period, five-sequence, crossover, at one study site Part 2: open label, one-treatment, one-period, at one study site
| Arm | Type | Receives |
|---|---|---|
| SINGLE DOSE- TEST PRODUCT 1 (T1) | Active comparator | Drug: Glucose 8 g coated beads (47% w/w)Oral coated beads 8 g glucose (content glucose/bead 47% w/w) |
| SINGLE DOSE- TEST PRODUCT 2 (T2) | Active comparator | Drug: Glucose 12 g coated beads (47% w/w)Oral coated beads 12 g glucose (content glucose/bead 47% w/w) |
| SINGLE DOSE- TEST PRODUCT 3 (T3) | Active comparator | Drug: Glucose 16 g coated beads (47% w/w)Oral coated beads 16 g glucose (content glucose/bead 47% w/w) |
| SINGLE DOSE- TEST PRODUCT 4 (T4) | Active comparator | Drug: Glucose 12 g uncoated beadsOral uncoated beads 12 g glucose |
| SINGLE DOSE- TEST PRODUCT 5 (T5) | Active comparator | Drug: Glucose 12 g coated beads (60% w/w)Oral coated beads 12 g glucose (content glucose/bead 60% w/w) |
| MULTIPLE DOSE- TEST PRODUCT 2 (T2) | Active comparator | Drug: Glucose 12 g coated beads (47% w/w)Oral coated beads 12 g glucose (content glucose/bead 47% w/w) |
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)
Key exclusion criteria (27 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, prazoles)
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 |
|---|---|---|
| Glucose 8 g coated beads (47% w/w)Also: APHD-008After an overnight fasting of about 10 hours, the subjects were administered 8 g glucose of the coated Glucose beads formulation starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position. | Drug | SINGLE DOSE- TEST PRODUCT 1 (T1) |
| Glucose 12 g coated beads (47% w/w)Also: APHD-012After an overnight fasting of about 10 hours, the subjects were administered 12 g glucose of the coated Glucose beads formulation starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position. | Drug | SINGLE DOSE- TEST PRODUCT 2 (T2) |
| Glucose 16 g coated beads (47% w/w)Also: APHD-016After an overnight fasting of about 10 hours, the subjects were administered 16 g glucose of the coated Glucose beads formulation starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position. | Drug | SINGLE DOSE- TEST PRODUCT 3 (T3) |
| Glucose 12 g uncoated beadsAlso: APHD-012PAfter an overnight fasting of about 10 hours, the subjects were administered the uncoated Glucose beads formulation containing 12 g glucose starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position. | Drug | SINGLE DOSE- TEST PRODUCT 4 (T4) |
| Glucose 12 g coated beads (60% w/w)Also: APHD-012-60After an overnight fasting of about 10 hours, the subjects were administered the coated Glucose beads formulation (60 % w/w glucose/bead; 12 g glucose) starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position. | Drug | SINGLE DOSE- TEST PRODUCT 5 (T5) |
| Glucose 12 g coated beads (47% w/w)Also: APHD-012After an overnight fasting of at least 10 hours, the subjects were administered the new developed Glucose beads formulation containing 12 g glucose starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position. Treatment duration: Day 1 - Day 4 | Drug | MULTIPLE DOSE- TEST PRODUCT 2 (T2) |
Primary outcome
GLP-1
Time frame: Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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.
Part 1: Area under the plasma concentration-time curve from the first time point zero to the last measured concentration (AUC[0-t])
GLP-1
Time frame: Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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.
Part 1: Area under the plasma concentration-time curve from the time point 1.5 hours to 8 hours (AUC[1.5 hours-8 hours])
GLP-1
Time frame: Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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.
Part 1: Adjusted area under the plasma concentration-time curve from the time point 1.5 hours to 8 hours (AUCadj.[1.5 hours-8 hours])
GLP-1
Time frame: Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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.
Part 1: Maximum plasma concentration (Cmax[0-t])
GLP-1
Time frame: Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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.
Part 1: Maximum plasma concentration between the time point 1.5 hours to 8 hours (Cmax[1.5 hours-8 hours])
GLP-1
Time frame: Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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.
Part 1: Adjusted maximum plasma concentration between the time point 1.5 hours to 8 hours (Cmax,adj.[1.5 hours-8 hours])
GLP-1
Time frame: Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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.
Part 1: Time of maximum plasma concentration (tmax[0-t])
GLP-1
Time frame: Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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.
Part 1: Time of maximum plasma concentration between the time point 1.5 hours to 8 hours (tmax[1.5 hours-8 hours])
GLP-1
Time frame: Day 1-3:- pre-dose (-1.0 hour, -0.5 hour and 0 hour). Day 4:- Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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.
Part 2: Area under the plasma concentration-time curve during a dosage interval at steady state (AUC[0-τ])
GLP-1
Time frame: Day 1-3:- pre-dose (-1.0 hour, -0.5 hour and 0 hour). Day 4:- Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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.
Part 2: Maximum plasma concentration at steady state (Cmax,ss)
GLP-1
Time frame: Day 1-3:- pre-dose (-1.0 hour, -0.5 hour and 0 hour). Day 4:- Pre-dose (-1.0 hour, -0.5 hour and 0 hour [within 5 minutes]) 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.
Part 2: Concentration at the end of the dosing interval at steady state (Cτ,ss)
6 secondary outcomes
Glucose levels
Time frame: Pre-dose (-1.0 hour, 0 hour [within 5 minutes]) 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.
Glucose levels
Time frame: Pre-dose (-1.0 hour, 0 hour [within 5 minutes]) 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.
Glucose levels
Time frame: Day 1- Day 3:- Pre-dose (3 samples). Day 4:- Pre-dose (-1.0 hour, 0 hour [within 5 minutes]) 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.
Glucose levels
Time frame: Day 1- Day 3:- Pre-dose (3 samples). Day 4:- Pre-dose (-1.0 hour, 0 hour [within 5 minutes]) 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 appetite
Time frame: Pre-dose (0 hour) and 2, 3, 4, 5, 6, 8 and 10 hours after investigational product administration.
Visual analogue scale stomach rumbles
Time frame: Pre-dose (0 hour) and 2, 3, 4, 5, 6, 8 and 10 hours after investigational product administration.
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 18 Sep 2025.
- 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 principal investigator
NovaClin Medical Research Center S.R.L
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 Glucose 8 g coated beads (47% w/w), Glucose 12 g coated beads (47% w/w) and Glucose 16 g coated beads (47% w/w) in people with Obese, 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 27 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 18 Sep 2025. 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 hour, -0.5 hour and 0 hour [within 5 minutes]) 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 11 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 18 Sep 2025.