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NCT02480439
A Phase 1, Randomized, Open-Label, Single-Dose, 3-Way Crossover Study to Assess the Relative Bioavailability of a TAK-648 Tablet Compared With a TAK-648 Oral Solution, and to Assess the Effect of Food on the Bioavailability of a TAK-648 Tablet in Healthy Participants
Phase 1 trial testing TAK-648 Tablet in Healthy Volunteers in 24 participants. Completed in 1 September 2015.
1 August 2015
Quick facts
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 1 June 2015 |
| Primary completion | 1 August 2015 |
| Estimated completion | 1 September 2015 |
| Sites | 1 location across United States |
Drugs / interventions tested
- TAK-648 Tablet — full drug profile →
- TAK-648 Oral Solution
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Takeda — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy Volunteers. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Cmax: Maximum Observed Plasma Concentration for TAK-648
Time frame: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period -
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648
Time frame: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period -
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648
Time frame: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period
Sponsor's own description
The purpose of this study is to assess the relative bioavailability of a TAK-648 tablet compared with a TAK-648 oral solution, and to assess the effect of food on the bioavailability of a TAK-648 tablet in healthy participants.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Role of Phosphodiesterase in the Biology and Pathology of Diabetes.
Kilanowska A, Ziółkowska A. · · 2020 · cited 20× · PMID 33153226 · DOI 10.3390/ijms21218244
Verify or expand the search:
- PubMed search for NCT02480439
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02480439 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Takeda
- Last refreshed: 19 July 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02480439.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing