PMID- 37248357
OWN - NLM
STAT- MEDLINE
DCOM- 20230629
LR  - 20230629
IS  - 1179-1918 (Electronic)
IS  - 1173-2563 (Linking)
VI  - 43
IP  - 6
DP  - 2023 Jun
TI  - A Phase I Study to Evaluate the Pharmacokinetic Drug‒Drug Interaction of HP501, 
      Febuxostat, and Colchicine in Male Chinese Patients with Hyperuricemia.
PG  - 401-411
LID - 10.1007/s40261-023-01274-7 [doi]
AB  - BACKGROUND AND OBJECTIVE: HP501 is a highly selective renal urate transporter 1 
      (URAT1) inhibitor that is being developed for the treatment of hyperuricemia and 
      gout. The primary aim of the present study was to study the pharmacokinetic 
      drug‒drug interactions (DDIs) of HP501, febuxostat, and colchicine in 
      hyperuricemic patients. METHODS: Hyperuricemic patients were randomly divided 
      into group A, receiving HP501 40 mg once daily on days 1 and 4-10, and group B, 
      receiving febuxostat 40 mg once daily on day 1 and HP501 40 mg plus febuxostat 40 
      mg on days 4-10. All patients received 0.5 mg colchicine once daily from day 4 to 
      12. Blood samples were collected for measurement of drug concentrations and serum 
      uric acid (sUA) levels. RESULTS: Coadministration of colchicine with HP501 or 
      HP501 plus febuxostat did not affect steady-state exposure to colchicine. 
      Coadministration of HP501 and febuxostat did not significantly change the 
      pharmacokinetic profiles of either drug. Following multiple administrations of 
      HP501 40 mg once daily for 7 days, the maximal percent sUA change from baseline 
      in group A was - 24.77%. The coadministration of HP501 40 mg and febuxostat 40 mg 
      in group B for 7 days resulted in a - 55.82% maximal sUA reduction from baseline, 
      and all patients achieved the goal of sUA < 360 mumol/L. All adverse events (AEs) 
      were either mild or moderate, and the most frequently reported AEs were diarrhea 
      and elevated alanine aminotransferase (ALT) levels. CONCLUSIONS: The concomitant 
      use of HP501, febuxostat, and colchicine did not produce clinically meaningful 
      DDIs in terms of their pharmacokinetic properties. CLINICAL TRIAL REGISTRATION: 
      No. CTR20212261 ( http://www.chinadrugtrials.org.cn/ ) registered September 2021.
CI  - (c) 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
FAU - Ding, Ruilin
AU  - Ding R
AD  - Institute of Drug Clinical Trial/GCP Center, The Affiliated Hospital of Southwest 
      Medical University, Luzhou, Sichuan, China.
FAU - Chen, Longxia
AU  - Chen L
AD  - Institute of Drug Clinical Trial/GCP Center, The Affiliated Hospital of Southwest 
      Medical University, Luzhou, Sichuan, China.
FAU - Li, Xinghai
AU  - Li X
AD  - Hinova Pharmaceuticals Inc., Chengdu, Sichuan, China.
FAU - Xiong, Tengqiong
AU  - Xiong T
AD  - Institute of Drug Clinical Trial/GCP Center, The Affiliated Hospital of Southwest 
      Medical University, Luzhou, Sichuan, China.
FAU - Chen, Hong
AU  - Chen H
AD  - Institute of Drug Clinical Trial/GCP Center, The Affiliated Hospital of Southwest 
      Medical University, Luzhou, Sichuan, China.
FAU - Hu, Xiaojing
AU  - Hu X
AD  - Institute of Drug Clinical Trial/GCP Center, The Affiliated Hospital of Southwest 
      Medical University, Luzhou, Sichuan, China.
FAU - Li, Yun
AU  - Li Y
AD  - Institute of Drug Clinical Trial/GCP Center, The Affiliated Hospital of Southwest 
      Medical University, Luzhou, Sichuan, China.
FAU - Zhou, Yi
AU  - Zhou Y
AD  - Hinova Pharmaceuticals Inc., Chengdu, Sichuan, China.
FAU - Liu, Kezhi
AU  - Liu K
AD  - Department of Psychiatry, The Affiliated Hospital of Southwest Medical 
      University, Luzhou, China.
FAU - Wu, Jianhong
AU  - Wu J
AD  - Department of Rheumatology, Dazhou Central Hospital, Dazhou, Sichuan, China.
FAU - Jiang, Feng
AU  - Jiang F
AD  - Department of Cardiology, The Affiliated Hospital of Southwest Medical 
      University, No. 25 Taiping Street, Jiangyang District, Luzhou, 646000, China. 
      jfeng_06@126.com.
FAU - Peng, Qing
AU  - Peng Q
AUID- ORCID: 0000-0003-1372-1993
AD  - Department of Cardiology, The Affiliated Hospital of Southwest Medical 
      University, No. 25 Taiping Street, Jiangyang District, Luzhou, 646000, China. 
      qingpeng9712118@163.com.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20230530
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
RN  - 101V0R1N2E (Febuxostat)
RN  - SML2Y3J35T (Colchicine)
RN  - 0 (Gout Suppressants)
RN  - 268B43MJ25 (Uric Acid)
RN  - 0 (Uricosuric Agents)
SB  - IM
MH  - Humans
MH  - Male
MH  - *Febuxostat/adverse effects
MH  - *Hyperuricemia/drug therapy
MH  - Colchicine/adverse effects
MH  - Gout Suppressants
MH  - Uric Acid
MH  - East Asian People
MH  - Treatment Outcome
MH  - Uricosuric Agents/therapeutic use
EDAT- 2023/05/30 01:06
MHDA- 2023/06/29 06:42
CRDT- 2023/05/29 23:23
PHST- 2023/05/07 00:00 [accepted]
PHST- 2023/06/29 06:42 [medline]
PHST- 2023/05/30 01:06 [pubmed]
PHST- 2023/05/29 23:23 [entrez]
AID - 10.1007/s40261-023-01274-7 [pii]
AID - 10.1007/s40261-023-01274-7 [doi]
PST - ppublish
SO  - Clin Drug Investig. 2023 Jun;43(6):401-411. doi: 10.1007/s40261-023-01274-7. Epub 
      2023 May 30.