Pharmacokinetics and Tolerability of Minodronic Acid and Food and Age Effects on the Pharmacokinetics

NCT02295436 | Completed Phase 1 DMC

• 1 other identifier: WHXH-MINO
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoporosis

Keywords

minodronic acid; pharmacokinetics; tolerability; food; age; Chinese subjects

Outcome Measures

Primary Outcomes (2)

• Cmax

  the maximum observed plasma concentration and

  two months

• AUC

  the area under the concentration-time curve

  two months

Secondary Outcomes (1)

• adverse events

  two months

Study Arms (4)

1-mg group

EXPERIMENTAL

Twelve healthy young subjects were administered a single oral dose of 1 mg minodronic acid tablets at day 1 and then received repeated oral doses of minodronic acid (1 mg) once daily for 7 days (day 3 to day 9).

Drug: minodronic acid

2-mg group

EXPERIMENTAL

Twelve healthy young subjects were administered a single oral dose of 2 mg minodronic acid tablets.

Drug: minodronic acid

4-mg group

EXPERIMENTAL

Twelve healthy young subjects were administered a single oral dose of 4 mg minodronic acid tablets under fasting state at period 1.After a washout period of 8 days, they received the same dosage under fed conditions (administrated 30 minutes before high-fat breakfast).

Drug: minodronic acid

1-mg elderly group

EXPERIMENTAL

Twelve healthy elderly subjects were administered a single oral dose of 1 mg minodronic acid tablets.

Drug: minodronic acid

Interventions

minodronic acid DRUG

comparison of different doses, ages and medication conditions

Also known as: YM529/ONO-5920

1-mg elderly group; 1-mg group; 2-mg group; 4-mg group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Related Publications (1)

• 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.

  PMID: 25748293 DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

YM 529

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Weiyong Li, PhD

  Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice director of the pharmacy department

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 20, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 20, 2014

Record last verified: 2014-11