Pharmacodynamics and Pharmacokinetics of 3 New Developed Coated Glucose Beads in 20 Obese Healthy Subjects
Condition: Metabolic Syndrome; Obesity
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Phase 1

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 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.
    

Intervention name(s): coated beads glucose (8 g) and caffeine anhydrous; coated beads glucose (8 g) and caffeine anhydrous; coated beads glucose (8 g) and caffeine anhydrous; coated beads glucose (8 g); uncoated beads glucose (8 g) and caffeine anhydrous
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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.; 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.; 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.
Other intervention name(s): APH-001A; APH-001B; APH-001C; APH-001D; APH-001E
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: single-dose, randomized, open label, five-treatment, five-period, five-sequence crossover, at one study site
Masking: None (Open Label)
Primary purpose: Treatment