Clinical trial NCT02295436: Pharmacokinetics and Tolerability of Minodronic Acid and Food and Age Effects on the Pharmacokinetics
Official title: Pharmacokinetics and Tolerability of Minodronic Acid Tablets in Healthy Chinese Subjects and Food and Age Effects on the Pharmacokinetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Keywords: minodronic acid
pharmacokinetics
tolerability
food
age
Chinese subjects
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of the the study was to evaluate the pharmacokinetic properties of minodronic acid tablets following single and multiple oral administration in healthy Chinese subjects. Additionally, the effects of age and food on minodronic acid pharmacokinetics was also explored.

Detailed description: This was a single-center, phase I study in healthy young (19-30 years) and elderly (60-65 years) volunteers, which was conducted in four parts. In Part 1, minodronic acid tablets were administered to young volunteers at doses of 1, 2, and 4 mg. In Part 2, after a single dose, young volunteers in the 1-mg dose group received repeated oral doses of minodronic acid once daily for 7 days. In Part 3, a single oral dose of minodronic acid 1 mg was administered to elderly volunteers. In part 4, after a washout period of 8 days, volunteers in the 4-mg dose group received a single dose of 4 mg minodronic acid under fed conditions (administrated 30 minutes before high-fat breakfast). Plasma samples were collected and plasma concentrations of minodronic acid were analyzed by LC-MS/MS. Tolerability was assessed throughout the study by physical examinations, vital signs measurement, laboratory analyses, and monitoring of adverse effects.

Eligibility criteria: Inclusion Criteria:

* Subjects were included based on the following criteria:

  * males or females aged 19 to 35 years for young subjects or aged 60 to 65 years for elderly subjects
  * body mass index between 19 and 24 kg/m2
  * thorax radiography and ECG with no abnormalities
  * normal blood pressure values
  * heart rate
  * laboratory test results (hematology, blood biochemistry, hepatic function, and urinalysis)
  * negative test results for HIV and hepatitis B.

Exclusion Criteria:

* Subjects were excluded if they had a heart disease or disorder
* A hepatic, renal, respiratory, immune system, or nervous system disorder
* Any of the following conditions:

  * pregnancy
  * breast-feeding
  * hypocalcemia
  * prescription or over-the-counter medication use (including herbal products) within 2 weeks before the initiation of the study
  * blood donation or participation in other clinical trials within 3 months before enrollment in the study
  * alcohol or drug abuse
  * smoking more than 10 a day
  * clinically significant allergies to drugs or foods
  * sitting blood pressure \<80/50 mm Hg or \>140/100 mm Hg
  * A ventricular rate \<60 beats/min or \>100 beats/min at rest.

Primary outcomes:
measure: Cmax
timeFrame: two months
measure: AUC
timeFrame: two months
Secondary outcomes:
measure: adverse events
timeFrame: two months
Other outcomes:
Locations:
Study officials:
affiliation: Tongji Medical College, Huazhong University of Science and Technology
name: Weiyong Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou Y, He X, Li H, Ni Y, Xu M, Sattar H, Chen H, Li W. Pharmacokinetics and tolerability of minodronic acid tablets in healthy Chinese subjects and food and age effects on the pharmacokinetics. Clin Ther. 2015 Apr 1;37(4):869-76. doi: 10.1016/j.clinthera.2015.01.015. Epub 2015 Mar 5.